IDF Endorses Early Bariatric Surgery

Return on Investment Make Gastric Bypass Cost-Effective, Claims Position Statement Issued at 2nd World Congress on Interventional Therapies for Type 2 Diabetes

The International Diabetes Federation (IDF) has issued a "radical statement" at an international conference today saying gastric banding and similar surgeries should no longer be a last resort for severely obese people with type 2 diabetes, it is recommending that surgery be considered at a much earlier stage.

"The statement highlights that there is increasing evidence that the health of obese people with type 2 diabetes, including their glucose control and other obesity related comorbidities (conditions), can benefit substantially from bariatric surgery under certain circumstances," says the IDF press release.

The IDF says gastric banding and other surgeries to alter stomach anatomy should now be considered much earlier in the treatment of type 2 diabetes.
Gastric bypass surgery works by reducing the size of the stomach so a person can't eat as much and shortening the length of the intestine so that the body doesn't absorb too many calories. But it might also have the side effect of normalizing blood sugar.

Summary of the 39-Page Statement

• Obesity and type 2 diabetes are serious chronic diseases associated with complex metabolic dysfunctions that increase the risk for morbidity and mortality.
• The dramatic rise in the prevalence of obesity and diabetes has become a major global public health issue and demands urgent attention from governments, health care systems and the medical community.
• Continuing population-based efforts are essential to prevent the onset of obesity and type 2 diabetes. At the same time, effective treatment must also be available for people who have developed type 2 diabetes
• Faced with the escalating global diabetes crisis, health care providers require as potent an armamentarium of therapeutic interventions as possible.
• In addition to behavioral and medical approaches, various types of surgery on the gastrointestinal tract, originally developed to treat morbid obesity (“bariatric surgery”), constitute powerful options to ameliorate diabetes in severely obese patients, often normalizing blood glucose levels, reducing or avoiding the need for medications and providing a potentially cost-effective approach to treating the disease.
• Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies, especially when there are other major co-morbidities.
• Surgery should be an accepted option in people who have type 2 diabetes and a BMI of 35 or more
• Surgery should be considered as an alternative treatment option in patients with a BMI between 30 and 35 when diabetes cannot be adequately controlled by optimal medical regimen, especially in the presence of other major cardiovascular disease risk factors.2
• In Asian, and some other ethnicities of increased risk, BMI action points may be reduced by 2.5 kg/m
• Clinically severe obesity is a complex and chronic medical condition. Societal prejudices about severe obesity, which also exist within the health care system, should not act as a barrier to the provision of clinically effective and cost-effective treatment options.
• Strategies to prioritize access to surgery may be required to ensure that the procedures are available to those most likely to benefit.
• Available evidence indicates that bariatric surgery for obese patients with type 2 diabetes is cost-effective.
• Bariatric surgery for type 2 diabetes must be performed within accepted international and national guidelines. This requires appropriate assessment for the procedure and comprehensive and ongoing multidisciplinary care, patient education, follow-up and clinical audit, as well as safe and effective surgical procedures. National guidelines for bariatric surgery in people with type 2 diabetes and a BMI of 35 or more need to be developed and promulgated.
• The morbidity and mortality associated with bariatric surgery is generally low, and similar to that of well-accepted procedures such as elective gall bladder or gall stone surgery.
• Bariatric surgery in severely obese patients with type 2 diabetes has a range of health benefits, including a reduction in all-cause mortality.
• A national registry of persons who have undergone bariatric surgery should be established in order to ensure quality patient care and to monitor both short and long-term outcomes. 1.17 In order to optimize the future use of bariatric surgery as a therapeutic modality for type 2 diabetes further research is required.

Although such operations cost anywhere from $20,000 to $30,000, they will reduce healthcare expenditures in the long run, according to a new IDF position paper on the subject. The surgery, the IDF explains, often normalizes blood glucose levels and reduces or avoids the need for medication.

In addition, curbing diabetes can stave off costly complications such as blindness, limb amputations, and dialysis, says Francesco Rubino, MD, director of the IDF's 2nd World Congress on Interventional Therapies for Type 2 Diabetes.

"When we talk about whether we can afford bariatric surgery, we have to ask what will be the cost if we don't treat the patient. Studies have shown the surgery to be cost-effective. So there is a return on investment," says Francesco Rubino, MD, director of the IDF's 2nd World Congress on Interventional Therapies for Type 2 Diabetes

The IDF puts the lifetime cost of diabetes in the United States at $172,000 for a person diagnosed at age 50 years and $305,000 at age 30 years. More than 60% of this amount is incurred in the first 10 years after diagnosis.

The new recommended indications for performing bariatric surgery on patients who are both diabetic and obese match those announced last month by the US Food and Drug Administration for expanded use of the Lap-Band Adjustable Gastric Banding System (Allergan) to treat obesity.

The IDF recommendations dovetail with Dr Rubino’s previous research on how bariatric surgery alleviates diabetes. He showed that the effect on diabetes is not entirely explained by a person’s weight loss. In fact, the gastrointestinal tract serves as an endocrine organ and a key player in the regulation of insulin secretion, body weight and appetite, which is why altering the GI tract has such profound metabolic effects.

However, the use of bariatric surgery to treat diabetes has sparked controversy in healthcare circles. Critics question the wisdom of wielding a scalpel to solve a medical problem, especially when clinicians have more drugs at their disposal to deal with diabetes.

A study published online last week in the Archives of Surgery has raised doubts about the efficacy of LAGB. Researchers following 151 patients who underwent LAGB for obesity concluded that the procedure yielded "relatively poor long-term outcomes," with nearly half the patients needing their bands removed and 60% overall requiring some kind of reoperation. The authors, who performed the surgeries in question during the mid-1990s, added a caveat: they had used an older dissection technique.

Indeed, the biggest danger is that new weight-loss options likeEndoBarrier (developed in the UK), Lap-Band, Roux-en-Y gastric bypass and sleeve gastrectomy surgery have the potential to encourage overweight people to abandon traditional diet and exercise for procedures that carry some serious risks. That should be a big worry for all diabetes educators and activists.

Diabetic Diet: Is Determining Glycemic Load Better Than Counting Carbs?

To count carbs or discount them ‒ the debate continues. Being type 2 insulin dependent, I’m trying to make sense of the differing conclusions of two studies that have been published recently. It’s hard to say what these studies really show ‒ it can get confusing with all the information out there ‒ especially when pilaf (pilao) is on Sunday’s lunch menu!

Dr. Andrea Laurenzi of San Raffaele Vita-Salute University in Milan suggests that diabetes patients may benefit from counting the number of carbohydrates in their diet. In a small study ‒ published online in the America Diabetes Association journal Diabetes Care ‒ the Milan researchers looked at 61 adults on insulin pump therapy and found that those who learned to count carbs had a small reduction in weight and waist size after 6 months. Additionally, they reported gains in quality of life and an improvement in blood sugar levels.

On the other hand, Jiansong Bao at the University of Sydney in Australia, says the number of carbs alone might not be the best way to go. Writing in the American Journal of Clinical Nutrition, he feels that how many carbs you eat might be less important for your blood sugar than your food's glycemic load, a measure that also takes into account how quickly you absorb those carbs.

Dr. Sanjeev Mehta, of the Joslin Diabetes Center and Harvard Medical School in Boston says while Laurenzi’s findings do not prove that carb counting is the answer for people with type 1 diabetes, it is widely recommended that people on insulin try to estimate the carbohydrate content of their meals to help calculate their insulin doses. Indeed, a few other studies too have suggested that carbohydrate counting can help people with type 1 diabetes control their blood sugar levels.

There are books and online resources available for people who are interested in learning how to count carbs. However, some people have difficulty learning or sticking with the method, Mehta noted, and benefit from help from a professional, such as a dietitian or certified diabetes educator.

Mayo Clinic nutritionist Katherine Zeratsky, R.D., L.D. explains counting carbohydrates is a method for controlling the amount of carbohydrates you eat at meals and snacks. This is because they have the greatest impact on your blood sugar. Eating consistent amounts of carbohydrates every day helps you control your blood glucose level.

But carbohydrates aren't the only dietary consideration when you have diabetes. You need to also limit fat and cholesterol and control the number of calories you consume. The best way to do this is to control portion sizes, she says.

“Eating a healthy diet helps you control your diabetes and reduces your risk of diabetes-related conditions, such as heart disease and stroke. So, just because a food contains no carbohydrates doesn't mean that you can eat it in unlimited amounts,” she cautions.

However, Bao claims the so-called glycemic load of a food, which also takes into account how quickly it makes the blood sugar rise, might work better. Foods with soluble fiber, such as apples and rolled oats, typically have a low glycemic index, one of the contributors to glycemic load. Foods with a low glycemic index cause the blood sugar to rise slowly, and so put little pressure on the pancreas to produce insulin.

The glycemic load is calculated by multiplying the amount of carbs in grams per serving by the food's glycemic index divided by 100. (The glycemic index for a variety of foods can be found here.)

The Sydney researchers say their findings also suggest that eating foods with high glycemic loads could be linked to chronic disease like type 2 diabetes ‒ which does not require insulin injections ‒ and heart disease by raising blood sugar and insulin levels.

The researchers took finger-prick blood samples from 10 healthy young people who ate a total of 120 different types of food ‒ all with the same calorie content. They also had two groups of volunteers eat meals with various staples from the Western diet, such as cereal, bread, eggs and steak. And the glycemic load repeatedly trumped the carb count in predicting the blood sugar and insulin rise after a meal.

A Reuters report quotes Dr. Edward J. Boyko ‒ a diabetes expert at the University of Washington in Seattle who wasn't involved in the Sydney study ‒ saying it wasn't certain the findings would hold up in people who aren't completely healthy, adding, long-term effects and other nutrients in the food might also be important for disease risk.

"It would just be speculation whether a dietary change like this would help people with type 2 diabetes." The most important problem, Boyko points out, remains pure and simple overeating. "The excess weight is the main thing we ought to focus on…The simplest message would be, eat less."

South Asians' Impaired Ability to Burn Fat Makes Them More Prone to Diabetes

With more than 50 million diabetics ‒ mainly type 2 ‒ India is facing a full-blown diabetes epidemic. Another100 million are at the stage of pre-diabetes. Only China suffers from far more cases of diabetes.

While anecdotal evidence suggests diabetes has assuming epidemic proportions in the subcontinent as a result of improved incomes but poorer lifestyle and dietary choices, especially among the middle class, a new study reveals that people from South Asia are at greater risk of developing type 2 diabetes because of the way their muscles burn and store body fat.

Researchers from the University of Glasgow, Scotland, analyzed the rates of fat metabolism in 20 men of South Asian origin and 20 white European men.

Their findings suggested that South Asian men have a lower rate of fat metabolism during exercise than their European counterparts, as well as reduced sensitivity to insulin – indicating a possible tendency towards glucose intolerance and type 2 diabetes.

The scientists said the association between fat metabolism rate and insulin sensitivity was due to key differences between the muscles of south Asians and Europeans.

They discovered that the expression of genes key to fat metabolism was lower in the muscles of south Asians, affecting their ability to process fat and thus increasing the risk of insulin resistance - a major factor in the development of type 2 diabetes.

Dr Jason Gill, who led the study, said: "Our results suggest that the ability of south Asians' muscles to use fat as a fuel is lower than in Europeans."

"In other words, if a south Asian man and a European man were walking alongside each other at the same speed, the south Asian man's muscles would be burning less fat and this may contribute to a greater risk of developing diabetes.”

Dr Victoria King, from British charity Diabetes UK, said: "This new insight could provide the basis for future studies looking at lifestyle, or drug interventions to enhance the uptake and burning of fat in muscles, reducing the risk of type 2 diabetes in this high risk group."

The study was published in the peer-reviewed medical journal PLoS One.

Diabetes Management: Metformin Gets Highest Marks in New Study

The cost of managing diabetes is going up all the time. And while pharmaceutical companies are doing a great job trying to develop new drugs, the overriding profit motive is sometimes prompting them to cut corners or suppress information that may prove to me inimical to their bottom line. A case in point is Avandia, which is now banned in many countries but still prescribed in the US, but with many caveats.

However, the safety of most diabetes drugs are time-tested — insulin was discovered in the early 1920s, and two of the other most commonly prescribed, metformin and sulfonylurea, have been around since the 1950s. Indeed, these drugs have five characteristics physicians look for in diabetes medications: few potential complications, safety, tolerability, ease of use and a low cost. (See my earlier post 'Look to Older, Longer-Studied Treatments here.)

It’s not surprising that Metformin, in combination or alone, remains the top choice for first-line treatment of type 2 diabetes because it demonstrates the best risk-benefit profile vs. other diabetes drugs, according to new data.

Most importantly, the newer drugs, which have no generic options, are significantly more expensive than older ones. One hundred metformin pills cost about $35.57, or 35 cents a pill, while 30 Januvia pills (a DPP-4 inhibitor) cost $192.52, or $6.42 a pill — nearly 18 times as much. Ask any diabetic and he’ll tell you why he shudders at the thought of taking the newer medication, especially if it’s out of pocket.

According to the new study, metformin, that has been around for more than 15 years, works just as well and has fewer side effects than a half-dozen other, mostly newer and more expensive classes of medication used to control the chronic disease, new Johns Hopkins research suggests.

In their report ‒ published online March 14 in the journal Annals of Internal Medicine ‒ the Johns Hopkins team found that metformin, an oral drug first approved by the US Food and Drug Administration (FDA) in 1995, not only controlled blood sugar, but was also less likely to cause weight gain or raise cholesterol levels.

“Metformin works for most people. It’s cheaper, there’s a generic form — it’s tried and true,” says study leader Wendy L. Bennett, M.D., M.P.H., an assistant professor in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine. “Our study shows that even though there are all these newer drugs, metformin works just as well and has fewer side effects.”

The team looked at several popular classes of oral diabetes medication — metformin (sold as Glucophage, Fortamet and others), second-generation sulfonylureas (Amaryl, Glucotrol and more), thiazolidinediones (Avandia and Actos) and meglitinides (Starlix and Prandin) — and added two new classes of drugs, dipeptidyl peptidase-4 (DPP-4) inhibitors (Januvia and Onglynza) and glucagon-like peptide-1 (GLP-1) receptor agonists (Byetta and Victoza), which are given by injection.

Results indicated that most medications used as monotherapy yielded comparable decreases in HbA1c (about one absolute percentage point on average throughout the course of a study). Metformin alone, however, lowered HbA1c more than DPP-4 inhibitors alone, and any type of combination therapy reduced HbA1c by about one absolute percentage point more than monotherapy.

Weight loss with metformin was a mean 2.5 kg more vs. TZDs and sulfonylureas. Other data also showed that combination metformin and GLP-1 agonists induced greater weight loss than other combination therapies, but the researchers said evidence supporting this finding was weak.

When compared with pioglitazone, sulfonylureas and DPP-4 inhibitors, metformin also significantly lowered LDL. Further, the drug decreased triglycerides and moderately raised HDL.

The researchers reported that sulfonylureas raised the risk for hypoglycemia four-fold vs. metformin monotherapy. Combination treatment with metformin and a sulfonylurea also had a six-fold higher risk for hypoglycemia than combination metformin and TZDs.

Analysis of other adverse events revealed that risk for congestive heart failure was higher with TZDs than with sulfonylureas. Risk for bone fractures was also higher with TZDs than with metformin alone or metformin combined with sulfonylurea. Diarrhea, however, was more commonly associated with metformin than with other medications.

“Although the long-term benefits and harms of diabetes medications remain unclear, the evidence supports use of metformin as a first-line treatment agent,” the researchers wrote.

The study is an update of Hopkins research published in 2007 that also showed there were advantages to metformin. New classes of medication for adult-onset diabetes have been approved by the FDA since then, and Bennett and her colleagues wanted to know if the newer drugs were any better than the older crop.

The research team also looked for the first time at the efficacy of two-drug combinations to treat the chronic disease, which has become increasingly common with more than one-third of diabetes patients needing multiple medications.

Researchers found that while two drugs worked better than one in those patients whose blood sugar remained poorly controlled on a single medication, there were also side effects associated with adding a second medication.

“Diabetes is an enormous public health problem, and patients have difficult decisions to make about what medications they should be taking,” Bennett says. “Our study provides good information comparing drugs and can be used to inform those decisions.”

Bennett and her colleagues reviewed 166 previously published medical studies that examined the effectiveness and safety of diabetes drugs, as well as their impact on long-term outcomes including death, cardiovascular disease, kidney disease and nerve disease.

No drug or combination of drugs was shown to have an advantage in improving long-term outcomes, Bennett says, primarily because there weren’t enough long-term studies, particularly of newer medications.

While most drugs reduced blood sugar similarly, metformin was consistently associated with fewer side effects. Though metformin is associated with increased risk of gastrointestinal side effects, Bennett, an internist, says she finds many of her patients can overcome them by starting with a low dose and taking it with meals, though patients with severe kidney disease may avoid it.

The sulfonylureas and meglitinides were associated with increased risk for hypoglycemia, or dangerously low blood sugar levels. The thiazolidinediones increased risk of heart failure, weight gain and fractures. In September 2010, the FDA placed restrictions on the use of Avandia because of concerns that the drug increases the risk of heart attack.

While the drugs all reduce blood sugar levels, Bennett says more research is needed into whether they actually improve outcomes for diabetics in the long run. It remains an open question as to whether patients with type 2 diabetes who have their blood sugar controlled by medication will reduce their chances of having complications associated with the disease, including eye, kidney and nerve diseases, she says.

“Some of the drugs haven’t been on the market long enough to study the long-term effects or even some of the short-term rare side effects, so we need longer studies in patients who are at highest risk for complications” she says.

Diabetes: Is the ADA Shifting its Stance About Carbs?

Carbohydrates are a very touchy subject with diabetics. And for me at least, understanding carbs in a diabetic diet is more difficult than quantum mechanics (or double-entry accounting if you’re not a science type). Diabetologists and dieticians, too, have differing views. I found this article by LAURA DOLSON very instructive and am reproducing it here for those who may have missed it. You can find the lively discussion that followed the article’s publication here.

You may be surprised to know that for the past couple of decades, the American Diabetes Association has been sort of a cheerleader for carbs. Yes, I'm talking about the organization who's mission it is to promote education and research in ways aimed at preventing diabetes and alleviating the suffering of diabetics.

What is diabetes? It is essentially a disorder of the body's ability to process carbohydrates. This includes Type 1 and Type 2 diabetes, pre-diabetes, metabolic syndrome, insulin resistance, and all the other points on the diabetes spectrum. (The Endocrine Society suggests that anyone with a fasting blood glucose of 89 or above is at risk for damage to their health.)

In light of this, you'd think that limiting carbohydrate intake would be a priority in educating people about handling these disorders. And yet, the ADA jumped right onto the Food Pyramid bandwagon and began to advise people to get at least 55% of their calories from carbohydrate, such as in the Food Pyramid for Diabetes (see illustration above).

In 2008, they made one exception: diabetics trying to lose weight could follow a low-carb diet for up to one year; this was later loosened further to two years. But still they did not recommend a low-carb diet for health, blood sugar control, or preventing progression of the diabetes.

Now, in the March 2011 edition of the ADA magazine "Diabetes Forecast" are three rather remarkable articles. The first is called The "ADA Diet" Myth, which claims that there is no such thing as the ADA Diet! (Who else was having this hallucination?) Instead, Stephanie Duncare, director of nutrition and medical affairs for the ADA says, "For more than 15 years now, ADA has recognized that people with diabetes should eat in a way that helps them reach their blood glucose, cholesterol, blood pressure, and weight goals. For some, this means a relatively higher-carbohydrate diet, and for others, the diet may be lower in carbohydrate". Well, hallelujah to that, especially if the goal is "normal blood glucose" (normal meaning "a blood glucose level that will not cause further damage in the pancreas").

Even more bold is an article called, "Are Carbs the Enemy?" which attempts to cover the debate. They first present a sort of wimpy pro-carb stance. This section of the article has a notable absence of anything to do with science, instead relying on statements such as "Gone are the days of 'diabetic diets' that were meager and confining" and "as long as people eat less or cover their carb intake with medications, they can keep blood glucose levels in check with a healthy diet" ("healthy" in this case meaning "high-carb").

The article then goes on to describe a low-carb approach, citing Dr. Richard Bernstein. This section cites actual evidence, and makes what I think is a much stronger case for controlling blood glucose by limiting carbohydrates. The article goes on to a section on saturated fats which is much more balanced than usual, and then the normal "we don't have the long-term studies". The article concludes with the statement: "In the end, the best diet is the healthy one you're able to follow."

The only thing I would add is that people need support in making those changes, and as far as I can tell they are still leaving an awful lot up to the individual to figure it out for themselves. There has been quite a defeatist attitude coming from the organization that is supposed to be helpful - along the lines that it is asking just too much of people to cut carbs in any significant way. Are dietitians now actually going to support people in finding a diet that achieves as close to a normal blood glucose as possible? It would be a very big change if this happened any time soon.

But wait, there's more! A follow-on short piece called "Eating With Diabetes: 3 Approaches" lists the low-carb approach first, and then follows with "Moderate-Carb" and "Vegan/High-Carb". The weird thing is that the three approaches are described as "less than 10% carb", "40-50% carb" and "75% carb". What about people who normalize their blood glucose with 20% carb or 30% carb? Why not just say, "it's a spectrum disease, with a spectrum of carb that will treat it effectively"? In any case, I don't want to complain too loudly, because this is SO great to see in an ADA publication!

Now, to be sure, the ADA is not yet changing their basic stance. Nowhere on the latest update of the diabetes.org Web site is it stated that diabetics should follow a low-carb diet. On the other hand, there is no longer anything I can find that says to eat over half of calories from carbohydrate, either. The former food pyramid, as far as I can tell, has vanished, and there are several hints that low-carb eating is becoming a bona-fide option.

There are statements such as, "Understanding the effect of carbohydrate on blood glucose levels is key to managing diabetes. The carbohydrate in food makes blood glucose levels go up." Although diabetics are still advised that "a place to start is at about 45-60 grams of carbohydrate at a meal.", (yikes) it goes on to say to adjust from there. Even though this is not what most of us would call a low-carb diet, for most people it is a reduction from their previous advice.

[Side note: I also notice it doesn't actually say 45-60 g/meal is a good place to start. If that actually controls someone's blood glucose, that's great, but I would think that in the cases where it doesn't, it would be more disheartening to subsequently take more carb away. Why not start lower, and then add? Also, most likely, the person for whom this works is losing weight - a phase which doesn't last forever.]

To me this looks like the beginnings of a real change in approach from the ADA. The Titantic may actually be turning around! This could make a difference to the health of millions of people, and nothing could make me smile more than that.

By Laura Dolson/about.com
Image courtesy about.com

Diabetes & Steroids

Some conditions (e.g. Addison's disease, severe asthma, rheumatoid arthritis, lupus) are treated with steroids. If you have diabetes, you may well find that your blood glucose levels rise while taking high-doses of steroids for periods of time.

This should not stop you taking steroids if your doctor has prescribed them, even if your blood glucose levels are affected, but you should discuss with your doctor how best to manage your diabetes while taking steroids. You may need an increase in medication or your medication to be changed.

If the steroids have been prescribed for a short period to manage a deterioration in your condition, your blood glucose levels will usually return to normal when you stop taking them. The drugs he’d been prescribed, glucocorticoids, are a type of steroid. And many people will take glucocorticoids not knowing a common side-effect is type 2 diabetes.

In fact, steroid-induced diabetes is “very common”, says Dr David Price, a diabetes expert at the Morriston Hospital at Swansea, UK. “Glucocorticoids are life-saving in many situations. But the unavoidable consequence is that they raise blood sugar.” The drugs mimic the hormone cortisol, which is produced by the adrenal gland.

Cortisol is known for its anti-inflammatory effect, which is why these medications are prescribed for inflammatory conditions such as arthritis and asthma — but it also affects the way the body metabolizes sugar.

“Cortisol is a stress hormone,” says Dr Price. “When you’re stressed, it acts to free up glucose from the liver because you need this energy to get to the muscles.” As a result, blood sugar levels go up. And while many people on glucocorticoids see their blood sugars drop back to safe levels once they stop taking steroids.

When older people are put on a big dose of steroids, for example, a significant minority would become diabetic. And if someone is already diabetic, they may go from being on tablets to having to inject themselves. Patients should be warned of the risks.

This is what a British man ‒ who was asthmatic but did not have diabetes ‒ was not told.

Tony had developed asthma in 2000; he was then diagnosed with bronchiectasis, a condition where some of the air passages become permanently widened, meaning extra mucus builds up and the patient is more prone to chest infections.

He was given inhalers to keep the conditions under control, but these weren’t enough. “I ended up in hospital four times with severe attacks,” recalls Tony, 65, a semi-retired communications consultant from London.

In hospital he was given oral steroids in the form of prednisone, to reduce the inflammation in his airways. He then developed nasal polyps and so started taking prednisone more regularly. Polyps are swellings in the nasal cavity which can cause a runny nose and, in Tony’s case, loss of sense of smell. “Doctors told me the steroids could help to shrink the polyps,” he recalls. “I took them only if my chest was troubling me, or when I travelled overseas for business meetings, to spare myself the embarrassment of a dripping nose.”

Tony’s doctors warned him not to take them too often because of serious side-effects such as a hormone disorder called Cushing’s syndrome, so he kept to no more than once every three months. But his doctors never mentioned another serious risk: that, in fact, glucocorticoids can cause diabetes.

“During a trip to South Korea, a day after taking a dose, I found myself very thirsty and tired, and needing to go to the loo a lot. I didn’t think much of it, but when I got home my jet lag didn’t recover. I was exhausted and I started losing weight. After two weeks of this, I Googled my symptoms. Straight away, diabetes came up,” recalls Tony

Concerned, Tony bought a home blood sugar test and found his levels were much higher than normal. He went to see his GP, who did more tests and confirmed he had type 2 diabetes.

Not only was Tony showing the symptoms of diabetes, a urine test showed the presence of ketones — acids which build up in the blood when a diabetic patient’s insulin is dangerously low. Ketones can lead to ketoacidosis, a cause of diabetic coma and even death.

“I told my doctor about my medication and he said: ‘You’ve got steroid-induced diabetes.’ I’d never heard of it,” says Tony. The GP sent Tony to the diabetes clinic at the local hospital. He was given insulin and shown how to administer the injections. Within days his tiredness and thirst had faded.

Doctors told him his type 2 diabetes would be with him for life. The drugs he had taken to ease his chest problems had left him with a permanent and potentially life-threatening condition. “No one told me the steroids could cause diabetes,” says Tony. “I felt gutted that for the rest of my life I’d have to inject myself.”

“However, in some cases there may be a slight problem with insulin production anyway — this won’t have been an issue before. But the steroids cause an added strain on the pancreas, causing the patient to become permanently diabetic. It can depend on the dose you’re on, and underlying risks like whether you’re overweight and whether there’s a family history of diabetes,” adds Dr Price.

Tony, however, had no family history of diabetes and was not overweight. He’d also had regular blood tests for years during routine medical checks, which he says had always been normal.

Frustrated at his experience, Tony began to question whether there was anything he could do about his new condition. “I knew insulin is a very unstable thing. If you get your doses wrong and your blood sugar goes too low, you can get diabetic ‘hypos’, and if you don’t control your diabetes you can have strokes, amputations, problems with eyesight, all kinds of things.

“On my fourth visit to the diabetic clinic I asked the nurse if I could try reducing my insulin dose slowly over time and see how it went. I did and my blood sugar went back to near normal within two to three weeks.

“The clinic confirmed I no longer needed to inject, but said I was still mildly diabetic, so they put me onto a daily Metformin tablet. That’s been the case for four years.” Tony now avoids glucocorticoids and his asthma has been greatly improved thanks to an inhaled steroid calledSeretide.

Tony is relieved he’s got his diabetes under control, but still wishes he’d been warned about the side-effects of glucocorticoids. “So many people have blind faith in their doctors. I wonder what would have happened if I hadn’t questioned my treatment.”

Adapted from a news report in the Daily Mail

Aggressive Diabetes Therapy May Raise Death Risk

The BIG news of the day is that intensive blood sugar control doesn't benefit people with both type 2 diabetes and heart disease. In fact, intensive treatment to lower blood sugar is linked to increased mortality, according to a long-running study whose findings were published today.

This reminds me of a discussion that I participated in a TuDiabetes forum a couple of week ago. The issue being discussed was A1c/eAG levels. I had written: “My diabetologist says that diabetics have higher eAG than normal, healthy individuals. Indeed, he says that it is better for diabetics to have an eAG of ~ 180 than ~ 140. He says in his experience diabetics who try to emulate normal eAG levels suffer more complications - cardio, renal, vascular, optho - than those with slightly higher values. He cites the example of a few patients (now age 80+) who have remained at 200+ for 30 years!”

Clinical trials now seem to have validated anecdotal evidence. The New England Journal of Medicine reported today that according to the latest analysis from the long-running ACCORD study, trying to maintain the blood sugar levels typical of people without diabetes can increase the risk of death for people with type 2 diabetes and heart disease by 19 percent.

ACCORD stands for Action to Control Cardiovascular Risk in Diabetes. This study was designed to assess whether intensive blood sugar interventions to bring A1C levels to under 6 percent would benefit people with type 2 diabetes and heart disease.

A1C is a long-term measure of blood sugar control, and the A1C level provides about two to three months of average blood sugar levels. A level of under 6 percent, which is considered normal or non-diabetic, can be difficult for someone with diabetes to achieve.

This brings me to the outlook of many TuDiabetes members (many of who take their management very seriously). Replying to my response mentioned above, one member wrote: “I disagree with the idea that lower blood sugar levels cause more complications….The largest intervention study to date, the DCCT pretty conclusively found that risks of "all" complications could be decreased by reducing blood sugars. Data from the DCCT conclusively substantiated that down to below 7% (154 mg/dl eAG). Further studies have found additional support that additional risk reductions occur all the way down to A1cs of even 5.5%. The American Association of Clinical Endochrinologists in fact suggests that patients "Encourage patients to achieve glycemic levels as near normal as possible without inducing clinically significant hypoglycemia".”

Another quipped: “If your diabetologist is implying that averaging 180 is okay (over the Renal Threshold), then he desperately needs to go on a high-fiber diet.”

Fair enough. All of agree that BS levels should be as close to normal as possible. But do we have to adopt an aggressive approach to diabetes management just because the doctors says so? Ground Zero observations have revealed that many diabetics do NOT suffer complications. (See my earlier post on this here.)

It should not be forgotten that aggressive insulin therapy also necessitates the need of continuous monitors, a luxury most diabetics cannot afford (given the high cost of testing strips). In India where I live, only a minuscule number of people test BS on a daily or even weekly basis. The norm is to test fasting and post-prandial levels only when one visits a diabetologist, which is not more than 2-3 times in a year. (My diabetologist says most of his patients turn up only when they're really sick.)

Of course I’m guilty of poorly paraphrasing my diabetologist’s observations. But essentially he’s right and the recent ACCORD study validates a diabetologist’s long experience of treating a variety of patients in a (clinically) ‘hostile’ environment.

It is interesting to note how the ACCORD study reached its conclusions. The people recruited for the study were between 40 and 79 years old, and their A1C levels were above 7.5 percent at the start of the study. Study volunteers were randomly assigned to either intensive blood sugar control or to a standard diabetes program striving for levels of 7 percent to 7.9 percent.

The study began in 2001 and was halted in February 2008 when researchers realized that people in the intensive treatment group had an increased risk of dying. By then, the intensive treatment group had received 3.7 years of treatment aimed at lowering their A1C levels to below 6 percent.

Achieving such tight blood sugar control often required numerous interventions, such as lifestyle changes along with medication, multiple medications or insulin therapy.

The analysis includes five years of data. For the intensive group, that meant an average of 3.7 years of intense treatment, followed by 1.3 years of standard therapy.

At the time the study was stopped, the intensive therapy group experienced a 21 percent reduction in the risk of heart attacks, but a 21 percent increase in the risk of all-cause mortality.

After five years, the researchers found that the risk of heart attacks was still decreased by 18 percent, but the increased risk of all-cause mortality also persisted. People in the intensive therapy group had a 19 percent increased risk of dying of any cause.

The study's lead author, Dr. Hertzel C. Gerstein, the Population Research Health Institute Chair in Diabetes Research at McMaster University in Hamilton, Canada, said many researchers have tried to tease out why intensive blood sugar control might up the risk of death, and so far, no one has succeeded. Causes that have been ruled out include low blood sugar levels (hypoglycemia) and the rapid change in blood sugar levels.

"This study really reminds us that we always need to be prudent. Even if we think something is the right thing to do, sometimes we may have findings that are unexpected," said Gerstein.

"This study confirms the results of the ACCORD trial over the full duration of the study," said Dr. Vivian Fonseca, president-elect of medicine and science for the American Diabetes Association.

"Overall, this means that the recommendations of the American Diabetes Association hold true. In general, people with diabetes should aim for an A1C goal of less than 7 percent, but clearly individualization is important. One size does not fit all," said Fonseca.

And, the findings suggest that people with type 2 diabetes and heart disease shouldn't attempt to achieve an A1C below 6 percent, the study authors said.

Gerstein and Fonseca noted that the ACCORD findings should not be generalized for everyone with diabetes. People with type 1 diabetes and those with type 2 diabetes and no history of heart disease were not included in this study.

"There is no reason to change current guidelines because of this study, and this study certainly doesn't support ignoring glucose control. We saw benefits in eye disease and many other outcomes with good control," said Gerstein.

More information

To learn more about the connection between diabetes, heart disease and stroke, go to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases

How Insulin-Producing Cells Die - Research Offers Potential for New Diabetes Diagnostic Test

The death of insulin-producing beta cells in the pancreas is a core defect in diabetes. Scientists in Italy and Texas now have discovered a new way that these cells die — by toxic imbalance of a molecule secreted by other pancreatic cells.

"Our study shows that neighboring cells called alpha cells can behave like adversaries for beta cells. This was an unexpected finding," said Franco Folli, M.D., Ph.D., professor of medicine/diabetes at The University of Texas Health Science Center at San Antonio. He is co-lead author on the study with Carla Perego, Ph.D., assistant professor of physiology at the University of Milan.

Alpha and beta cells are grouped in areas of the pancreas called the islets of Langerhans. Alpha cells make glucagon, the hormone that raises blood sugar during fasting. In the same environment the beta cells make insulin, the hormone that lowers sugars after a meal. Imbalance ultimately leads to diabetes.

"We found that glutamate, a major signaling molecule in the brain and pancreas, is secreted together with glucagon by alpha cells and affects beta cell integrity," Dr. Folli said. "In a situation where there is an imbalance toward more alpha cells and fewer beta cells, as in Type 1 and Type 2 diabetes, this could result in further beta cell destruction."

Glutamate toxicity is a new mechanism of beta cell destruction not previously known, Drs. Perego and Folli said. It has not been typically thought that alpha cells could themselves be a cause of beta cell damage, they said.

The study also found a protection for beta cells, namely, a protein called GLT1 that controls glutamate levels outside the beta cells. "GLT1 is like a thermostat controlling the microenvironment of beta cells with respect to glutamate concentration," Dr. Perego said.

A diagnostic test for glutamate toxicity in the islets of Langerhans is being developed by the authors, Dr. Folli said. Eventually an intervention to slow the process could follow.

Glutamate poisoning is a new candidate mechanism for beta cell destruction in diabetes. Others are high glucose, buildup of a protein called amyloid, and free fatty acids, which are found in patients with type 2 diabetes.

"The vicious cycle in diabetes is that there are several substances that have been shown, also by us, to be toxic to beta cells," Dr. Folli said. "And now we have found a new one, glutamate."

Aspirin May Help Diabetics With Kidney Disease Avoid Heart Complications

A new study from a team of Japanese researchers at the Nara Medical University shows that low daily doses of aspirin may help reduce risk of heart disease in patients who have both type 2 diabetes and kidney disease.

Heart disease, as we all know, is the most common cause of death for individuals who have type 2 diabetes because persistently high levels of blood sugar in the veins causes inflammation that leads atherosclerosis, which is a hardening of the arteries that causes the heart to work harder, eventually causing it to wear out.

The research, published in the journal Diabetes Care, concludes that there appears to be a strong relationship between diabetes-induced kidney disease and aspirin therapy. If future studies bear out these results, aspirin could provide a simple solution to a major problem that affects millions of people.

"The current study demonstrated that low-dose aspirin therapy reduced the risk of atherosclerotic events in type 2 diabetic patients," the researchers wrote in their report.

For the study, researchers gave a group of more than 2,500 participants who had type 2 diabetes and kidney disease either an 81 mg daily dose of aspirin, a 100 mg daily dose or no aspirin at all. The researchers then tracked the participants' medical records for nearly five years. During this time they checked for instances of stroke, heart disease and peripheral artery disease.

They found that individuals who were in either of the groups that received aspirin had significantly fewer atherosclerosis-related incidences than those who did not receive aspirin.

"The current study demonstrated that low-dose aspirin therapy reduced the risk of atherosclerotic events in type 2 diabetic patients," the researchers conclude.

Confirmed: Fatty Liver Ups Type 2 Diabetes Risk

If you get diagnosed with a fatty liver during a routine check-up, sit up and take notice. Fat deposits in liver are an invitation to diabetes. Although fatty liver and insulin resistance are known to be associated, the relationship between the two in the development of type 2 diabetes mellitus (T2DM) is unclear.

However, a recent study published in The Endocrine Society's Journal of Clinical Endocrinology and Metabolism (JCEM) found that individuals with fatty liver were five times more likely to develop type 2 diabetes than those without fatty liver.

This higher risk seemed to occur regardless of the patient's fasting insulin levels, which were used as a marker of insulin resistance. People who consume more oily food, have a sedentary lifestyle, especially those who consume large quantities of alcohol, are at risk of getting the disease.

In recent years, fatty liver has become more appreciated as a sign of obesity and resistance to insulin, a hormone that controls the body's glucose levels. This new study ‒ 'Interrelationship between Fatty Liver and Insulin Resistance in the Development of Type 2 Diabetes' by Ki-Chul Sung and Sun H. Kim of Kangbuk Samsung Hospital, Sungkyunkwan University at Seoul, South Korea ‒ shows that fatty liver may be more than an indicator of obesity but may actually have an independent role in the development of type 2 diabetes.

There seems to be little awareness about the disease even among the physicians. “It is not as innocuous as it looks. It is known to develop into liver failure or liver cancer. Recent studies have shown that fatty liver also increased chances of diabetes,” says Dr Mishra, who is chairman of the Fortis-CDOC Centre for Excellence for Diabetes at New Delhi in India.

According to Kim, "Many patients and practitioners view fat in the liver as just 'fat in the liver,' but we believe that a diagnosis of fatty liver should raise an alarm for impending type 2 diabetes…Our study shows that fatty liver, as diagnosed by ultrasound, strongly predicts the development of type 2 diabetes regardless of insulin concentration."

In the Seoul study, researchers examined 11,091 Koreans who had a medical evaluation including fasting insulin concentration and abdominal ultrasound at baseline and had a follow-up after five years.

Regardless of baseline insulin concentration, individuals with fatty liver had significantly more metabolic abnormalities including higher glucose and triglyceride concentration and lower high-density lipoprotein cholesterol (sometimes called "good cholesterol") concentration.

Individuals with fatty liver also had a significantly increased risk for type 2 diabetes compare to those without fatty liver.

"Our study shows in a large population of relatively healthy individuals that identifying fatty liver by ultrasound predicts the development of type 2 diabetes in five years," said Kim. "In addition, our findings reveal a complex relationship between baseline fatty liver and fasting insulin concentration."

Also see my earlier report “Fatty Liver a Forerunner to Diabetes”

Victoza: Is It the New "Miracle Drug" for Type 2 Diabetes?

I had reported last year that Danish pharma giant Novo Nordisk’s gamble on Victoza, its new drug for Type 2 diabetes, often looked like a long shot.

The company’s scientists had spent nearly 10 years trying to develop a molecule that would act like a naturally occuring hormone called GLP-1. Once they did, there were still costly setbacks, puzzling questions and enormous doubts, none of which managed to thwart one researcher’s passionate belief in the hormone’s ability to be turned into a drug for lowering blood sugar.

GLP-1 is short for glucagon-like peptide 1, a naturally occuring compound that works on different organs to lower the levels of blood sugar. For overweight diabetics, there’s another benefit: GLP-1 attaches to a receptor in the brain to decrease appetite, which over time, leads to weight loss.

Since then, Victoza has been used by thousands of diabetics, all with varying results. While the majority are seeing lower blood sugars (some in the double digits) and weight loss, others are seeing no change or too much change. Many have claimed Victoza to be a type 2 diabetes "miracle drug". That said, doctors are quick to use Victoza as a second line drug when Metformin and other first line drugs aren't doing their jobs.

Newer drugs to combat diabetes is always good news for those who are living with the disease. As all of us know, managing diabetes is not easy. In fact, for most diabetics it seems like a losing battle. Then a new drug hits the market, raising hopes. But many a time, expectations are dashed when its is discovered that the so-called wonder drug has some rather unpleasant side effects.

In fact, in the case of Avandia, a landmark meta-analysis in 2007 showing a 43% increase in the risk of heart attack on rosiglitazone. People with diabetes are already at increased risk of heart problems.

Last year, GlaxoSmithKline spent billions of dollars last year settling claims. And Avandia has been banned in most countries and in the US its use is severely curtailed. For all practical purposes, diabetics around the world have stopped using Avandia even though its supposed to be a "wonder drug".

How Victoza was ‘Discovered”

Before we get down to finding out more about Victoza, a little background is in order.

Lotte Bjerre Knudsen, a senior scientist at Novo Nordisk, led the 20-year effort to develop Victoza. Before the drug received its brand name, it was known by its scientific name, liraglutide. And in the research laboratory, Knudsen’s dedication earned her the nickname “Mrs. Liraglutide.’’

“There were doubts about whether this would ever be a drug,’’ Knudsen said in an interview last year. “When you’re making something completely novel, it’s not so untypical.”

The promise of the GLP-1 class of drugs fueled the company’s efforts through major setbacks, including a flawed dosing study that cost researchers 18 months. With each setback, Knudsen had to defend the project to management.

Knudsen said her team postponed celebrating Victoza’s development until the drug was approved by US regulators. “It wasn’t good enough until we received that,” she said.

So What Exactly is Victoza?

Victoza (liraglutide injection) is a non-insulin once-daily injectable medication that may help improve blood sugar levels in adults with type 2 diabetes. It comes in an injectable pen form with three dosage levels. The first level (0.6 mg) is usually used for a week and then increased to the second level (1.2 mg). If the third level (1.8 mg) is needed, it is easily "dialed" and may be started after the body has adjusted to the 1.2 mg level.

Victoza works by helping the pancreas release the right amount of insulin. Victoza is 97% similar to a hormone in our bodies called GLP-1. This hormone is what helps us move sugar from our blood into our cells. Victoza has the same effect as GLP-1, and it also helps food move much more slowly through the stomach. Another benefit of Victoza is that it blocks the liver from releasing too much sugar by lowering the amount of glucagon, a hormone that tells the liver to release glucose into the bloodstream in order to bring glucose levels to normal.

How Do I use Victoza?

One of the great things about Victoza is that it is made for once-daily usage. The pen only has to be refrigerated up until the first use, and then it can be kept conveniently in a non-refrigerated spot, such as a purse or bedside table. Victoza can be injected at any time of day, regardless of food intake. It is recommended to inject Victoza at approximately the same time each day, however, for consistency.

To do the injection, a special needle (which must also be prescribed by your doctor) is placed on the tip of the pen. The dial at the bottom of the pen is then turned to the dosage prescribed by your doctor. The injection may be given in the stomach, thighs or arms (subcutaneously). Throw the needle away, replace the cap, and you're done!

Side Effects of Victoza

The most common side effects of Victoza are nausea, vomiting and diarrhea until the body is used to the medication. Most patients start out at the 0.6 mg level for this reason. Lightheadedness has also been reported. A list of all side effects can be found on Victoza's website.

Victoza and Thyroid Cancer

During Victoza's testing process, the medicine caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Victoza will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people.

Victoza and Weight Loss

Many people have claimed to lose a great deal of weight while on Victoza. Although Victoza is not a weight loss drug, medical studies have shown that most people taking it do lose weight. Since weight loss is an important component of living with type 2 diabetes, this is definitely an added benefit.

Important Points About Victoza

• Victoza is not insulin, and it is not known if it is safe and effective when used with insulin.
• Victoza is not recommended as the first choice for treating type 2 diabetes.
• Victoza can be used on its own or with other diabetic medications.
• Victoza should not be used with people with type 1 diabetes or with people with diabetic ketoacidosis.
• Victoza should not be used with children.
• Doctors may recommend that small increases be made when going from 0.6 mg to 1.2 mg and then to 1.8 mg. This is accomplished by increasing by "clicks" on the dial. This is very helpful when side effects are severe.
• Victoza can be costly, depending on insurance. Depending on the dosage, Victoza can cost up to $500 when not covered by insurance. Check with your pharmacy, and visit Victoza's website for coupons and information on getting your diabetes medication for free.

Making the decision to start Victoza is one that is strictly between a patient and his or her doctor. One must weigh the side effects against the benefits and make an informed choice. Victoza may be called a miracle drug for type 2 diabetes, but it is up to individuals to draw that conclusion when it comes to treating their own diabetes.

Promoting Self-Management is Essential to Properly Treat Type 2 Diabetes

One of the most important aspects of diabetes management is educating the patient to manage their condition themselves. This is known as Diabetes Self-Management Education, better known by its acronym DSME. It has been demonstrated by many studies that education works.

DSME is defined as the ongoing process of facilitating the knowledge, skill and ability necessary for effective self-management and is guided by evidence-based standards. Patients with diabetes who do not receive DSME are found to be four times more likely to develop a major complication of diabetes and incur higher diabetes-related hospital costs.

I support the concept of DSME, given the fact that many family doctors do not have enough knowledge to effectively advise diabetes patients (see my earlier post ‘Why most doctors are clueless about treating diabetes’) and visits to a specialist involve long waiting periods and longer commutes.

In this interesting interview conducted by Endocrine Today, Linda Siminerio, RN, PhD, CDE, director of the University of Pittsburgh Diabetes Institute, and associate professor at the University of Pittsburgh School of Medicine and the School of Nursing answers many questions regarding DSME.

How can physicians effectively educate patients who currently have type 2 diabetes?
I think it is always helpful when physicians have access to additional resources to support team-based care. For example, referral to dietitians and diabetes education programs can be a powerful adjunct for comprehensive, quality care given the limited time they have available to spend with their patients. I have been involved in many studies and national surveys on referral practices, and we found that physicians often do not refer patients to these programs.

How can physicians effectively educate patients who are at risk for developing type 2 diabetes?
It is important for physicians to know what lifestyle intervention resources that address weight reduction and physical activity are available in their communities so that they can refer patients appropriately. Local YMCAs that offer lifestyle programs can be a valuable resource for physicians and patients. For example, in Indiana, some YMCAs have adapted the Diabetes Prevention Program (DPP) into a 16-week diabetes reduction program in the community setting. In Pittsburgh, the Diabetes Prevention Resource Center offers a 12–week Group Lifestyle Balance (GLB) program adapted from the DPP that is offered at community sites and in primary care practices. Physicians and practice staff should explore their respective communities to find community-friendly resources for their patients at risk for chronic disease.

What are your recommendations for creating collaboration between physicians and educators?
Physicians can refer their patients to the American Diabetes Association Web site to learn about community-based, recognized self-management education programs. Additionally, the American Association of Diabetes Educators Web site provides a variety of education materials that can be downloaded.

Even if patients obtain referrals from their physicians to participate in a program, they may not attend. I recommend that educators be integrated in the practice so that the educator becomes a part of the practice team. Educators and physicians should work together. Other support mechanisms are available in communities, but they are not always used. Primary care physicians should work with others in the community, such as local pharmacists, to effectively educate patients.

How can physicians promote diabetes self-management?
Diabetes self-management education (DSME) should always be considered as part of the treatment plan, even if a patient is reported to have excellent metabolic control. Attention to self-care behaviors and psychosocial needs are equally as important as metabolic outcomes when managing a burdensome, chronic disease like diabetes. Active listening, providing accurate information and building a patient’s confidence are all important tools used in diabetes education. It is essential that physicians and everyone on the diabetes care team work together to support patient self-management by developing patient-centered goals that will be more likely to be achieved.

How do you determine the best treatment option for patients?
Every patient and situation is individual. Thus, it is important for everyone on the diabetes care team to take time to listen to the patient’s needs and desires. The physician, along with the team, should provide patients with the necessary information to build a realistic care plan. Patients need to be informed so they can make informed decisions about their own care.

Do patients who have received this sort of patient-centered care have better results in the long run versus patients who may not receive ongoing support?
Research shows that diabetes self-management is an important component of diabetes care and has an impressive effect on HbA1c levels. In a meta-analysis, diabetes education was reported to reduce HbA1c by 0.76%. Since a 1% decrease in HbA1c is associated with a dramatic reduction in myocardial infarctions, micro-vascular disease and death, a 0.76% reduction can be considered an enormous benefit. Further, duration of contact time between a patient and an educator is the only significant predictor of the DSME effect. This suggests that DSME alone is not sufficient to maintain improved behaviors and that sustained improvements require contact and follow up.

We also know that if education is not sustained or supported, then HbA1c levels go back up. So, we need to continue to explore opportunities for continued support. Community-based programs, like wellness programs, YMCAs, churches and senior centers are potential forums for community friendly self-management support systems.

Bran Cuts Death Risk in Type 2 Diabetes Mellitus Patients

Type 2 diabetes mellitus in many cases can be prevented by following a modified lifestyle. Studies have suggested that even those who have acquired the disease may well control or even reverse their condition by following a healthy diet.

For example, eating whole grain cereal particularly bran supplemented foods may help reduce risk of premature death in women with type 2 diabetes mellitus, a new study recently published in the journal Circulation suggests.

The study led by Meian He Ph.D. and colleagues from Harvard School of Public Health in Boston Massachusetts found eating high amounts of bran was not only associated with significantly reduced risk of death from all causes, but also from cardiovascular disease (heart disease and stroke) or CVD in women with type 2 diabetes mellitus.

Bran is a hard outer layer of cereal grains such as rice, corn, oats, barley, millet and wheat and consists of combined aleurone and pericarp. It is full of dietary fiver and omegas and contains high amounts of starch, protein, vitamins and dietary minerals.

Type 2 Diabetes mellitus is a health condition that can lead to serious complications including bladder control problems for women, heart disease and stroke, nerve damage, eye disease, erectile dysfunction, foot problems, and kidney failure.

Whole-grain consumption has early been associated with lower risk of heart disease and stroke and mortality in the general population, according to the background in the study report.

The study was meant to determine the association of whole grain, cereal fiber, bran and germ with all-cause and CVD-specific mortalities in women with type 2 diabetes mellitus.

For the study, 7,822 U.S. women with type 2 diabetes mellitus enrolled in the NUrse' Health Study were followed for up to 26 years during which 852 all-cause deaths and 295 CVD deaths were identified. Subjects' dietary intakes and potential confounders were assessed regularly with questionnaires.

The subjects were divided into five groups based on their intakes of whole grain, cereal fiber, bran and germ. After adjusted for age, the highest intakes of whole grain, cereal fiber, bran and germ were associated with a 16 to 31 percent reduction in the risk of death from all causes compared to the lowest intakes.

After further adjustment for possible lifestyle and dietary risk factors, only bran intake was correlated with reduced risk.

Specifically, women in the group with the highest intake of bran were 28 percent less likely to die from all causes compared to those in the group with the lowest intake. This is an inverse association with higher intake leading to lower risk of all-cause death.

Bran intake was also inversely associated with CVD-related death with the highest intake linked with 45 percent reduction in the risk of heart disease and stroke or CVD compared to the lowest intake.

The researchers concluded "Whole-grain and bran intakes were associated with reduced all-cause and CVD-specific mortality in women with diabetes mellitus. These findings suggest a potential benefit of whole-grain intake in reducing mortality and cardiovascular risk in diabetic patients."

Previous studies have suggested Mediterranean diet, green leafy vegetables, breastfeeding,brown rice, plant-based diet, soy foods, black tea, vitamin D, L-carnitine, turmeric, selenium,bitter melon, fish oil, psyllium fiber and drinking coffee may help prevent type 2 diabetes mellitus.

Meanwhile, half way across the world, S. Haripriya and S. Premakumari from Pondicherry University and Avinashilingam University for Women in India conducted a small trial and proved that eating wheat bran help type 2 diabetes mellitus patients better control their condition.

The trial involved 30 patients aged 45 to 50. Half were assigned 20 grams of wheat bran, which consisted of 42.8 percent dietary fiber, each day for a 6-month period. And another group of 15 diabetics were not given any bran supplements.

For the trial, blood samples were collected at baseline and at the end of the trial to analyse biochemical factors including serum fasting glucose levels, postprandial glucose levels, and glycosylated hemoglobin levels or HbA1C in all the type 2 diabetes mellitus patients.

In the group of diabetes mellitus patients receiving wheat bran supplements, compared to the levels at baseline, the fasting glucose levels at the end of the trial were reduced by an average of 22.8 mg/ml. Controls did not experience any significant change.

Those on the bran supplement also reduced serum postprandial glucose levels by 39.80 mg/ml and the glycosylated hemoglobin or HbA1C by nearly 2 percent while controls did not have any significant change.

HbA1C is considered the most reliable index of long term diabetes control. Blood sugar tends to fluctuate from day to day and even from hour to hour while HbA1C reflects a true average index of glucose control for a period of 2 to 3 months.

Both groups of diabetes mellitus patients at baseline had 8.39 to 8.45 percent, a level of HbA1C considered by the definition of American Diabetic Association under unsatisfactory control.

After the supplementation trial, diabetes mellitus patients reduced the index by 1.96 percent, pushing the index down to 6.41 percent, a level which is considered under good control.

Clinical Trial Will Test Whether Surgery Is the Best Option for Type 2 Diabetes, Even for Patients Who Aren't Obese

A new clinical trial at NewYork-Presbyterian Hospital/Weill Cornell Medical Center is among the first to test surgery specifically for Type 2 diabetes. The aim of the study is to understand whether surgery can control diabetes, as well or even better than the best medical treatment available today. This is the first study of its kind open to patients who are overweight or mildly obese.

Under current guidelines, bariatric surgery is only indicated for the treatment of severe or morbid obesity, defined as having a body mass index (BMI) of 35 or greater. By contrast, the new study is open to patients with a BMI as low as 26. Normal-weight individuals have BMI ranging between 19 and 25 and overweight individuals have BMI between 26 and 29, whereas a BMI above 30 defines obesity. Patients with a BMI below 26 and above 35 will not be considered for enrollment in the trial.

Previous research has shown that in severely obese patients (BMI greater than 35) gastric bypass surgery is a safe and effective way to treat Type 2 diabetes. It has been shown to improve or normalize blood glucose levels, reduce or even eliminate the need for medication, and lower the risk for diabetes-related death.

"There is preliminary evidence suggesting that that these results are attainable even in overweight or mildly-obese patients," says Dr.Francesco Rubino, chief of the gastrointestinal metabolic surgery program at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and associate professor of surgery at Weill Cornell Medical College.

In support of this belief, recommendations from the American Diabetes Association's January 2009 issue of Standards of Care: Diabetes Care, and from the Diabetes Surgery Summit Consensus Conference, published in the March 2010 issue Annals of Surgery, suggest that randomized clinical trials for the study of surgery in patients with BMI below 35 are priority for diabetes research.

"Having a potentially effective surgical option against diabetes does not mean that surgery is the best choice for every diabetic patient," Dr. Rubino adds. "We need rigorous, comparative clinical trials, like this one, in order to better understand when to prioritize surgery and when to recommend traditional medical treatment."

The new study is enrolling 50 patients with Type 2 diabetes who will be randomized to receive surgery -- specifically, Roux-en-Y Gastric Bypass -- or traditional medical therapy and intensive lifestyle modification. All patients will be counseled in lifestyle modification techniques like diet and exercise.

Dr. Rubino expects that there will be medical advantages for patients in both arms of the trial since those assigned to the medical arm will receive the most rigorous medical diabetes therapy available. A multidisciplinary team of diabetes and nutrition experts will take care of patients using the most current, approved drugs for diabetes as well as an intensive approach to lifestyle changes. Patients in the medical arm will also be offered the chance to switch study arms and have surgery free of charge after the study is complete, or earlier should their diabetes remain poorly controlled after medical and lifestyle therapy.

Beyond BMI

Dr. Rubino and his co-investigators believe their study may also help identify better criteria than BMI for selection of surgical candidates. "Using strictly BMI-based criteria may be practical, but it is medically inappropriate because, on its own. BMI does not accurately define the severity of diabetes or identify patients who are best suited to benefit from a surgical approach," says Dr. Rubino. "New criteria would not only help patients and clinicians, but also payers."

Because insurers use BMI-based criteria, bariatric surgery is currently not covered for patients with a BMI less than 35, regardless of the severity of their disease. Consequently, the study at NewYork-Presbyterian/Weill Cornell is supported by a research grant from Covidien covering the cost of surgery for patients enrolled in the study.

A Look at How Diabetes Surgery Works

Previous research by Dr. Rubino studied how bariatric surgery alleviates diabetes, showing that the effect on diabetes is not entirely explained by a person's weight loss. In fact, the gastrointestinal tract serves as an endocrine organ and a key player in the regulation of insulin secretion, body weight and appetite, which is why altering the GI tract has such profound metabolic effects.

The current study aims to shed more light on the mechanisms of action of gastric bypass on diabetes. To do this, Dr. Rubino and his co-investigators will measure gut hormone responses to meal stimulation when an equivalent amount of weight loss has been achieved in both surgically and conventionally treated patients. This design may help uncover endocrine effects specific to gastric bypass surgery beyond those associated with non-surgical weight loss.

"Understanding how gastric bypass surgery functions may help us learn how diabetes works," Dr. Rubino says. "This knowledge has the potential to lead to the development of new minimally invasive procedures, devices interventions and better pharmaceutical treatments."

Toward an International Consortium

Dr. Rubino hopes that the current study will be a template for larger, international studies. "We intend this study to serve as a core protocol for similar randomized clinical trials independently run at other institutions as part of a worldwide consortium coordinated through the Diabetes Surgery Center at NewYork-Presbyterian/Weill Cornell," he says. "The consortium will provide a larger pool of patients allowing researchers to better evaluate the impact of surgery on various health measures, including cardiovascular risk and life expectancy."

The global prevalence of Type 2 diabetes is rising dramatically. "If proven successful, diabetes surgery has the potential to help millions of patients in the U.S. and worldwide," Dr Rubino says.

According to International Diabetes Federation (IDF), there are currently 285 million people with the disease around the world, a number that is expected to rise to 438 million by 2030. Diabetes is one of the greatest public health threats in the 21st century and a risk factor for vascular damage and eye, kidney and cardiovascular diseases, as well as death. Type 2 diabetes results from inadequate insulin production and action, and is associated with metabolic dysfunctions involving lipid metabolism and blood pressure regulation.

Interested patients with Type 2 diabetes may contact the Diabetes Surgery Center at NewYork-Presbyterian/Weill Cornell at (212) 746-5925 or ant2026@med.cornell.edu.

For more information, visit www.nyp.org and weill.cornell.edu.

Type 2 Diabetes Epidemic in US Linked to Profit-Making Food Industry

According to the 2011 National Diabetes Fact Sheet released by the United States Centers for Disease Control (CDC) on January 26, last year saw an increase in the numbers of people with diabetes in virtually every age category.

The federal agency reports that some 25.8 million Americans, or 8.3 percent of the total population, have diabetes. Fully a third of these individuals do not know that they have the disease and are unaware of the serious risks it creates for their health. In a staggering indictment of the state of public health in the US, the CDC found that a further 79 million people in the country are prediabetic, meaning that their blood sugar levels are elevated, but not yet to the point where they meet the criteria for a full diabetes diagnosis.

Even these stark statistics likely under-report the real situation, with research showing that 35 percent to 40 percent of deceased diabetics did not have the disease listed anywhere on their death certificates.

Ninety percent of diabetics in the US have Type II diabetes, which, as the CDC report points out, is preventable. Once a diagnosis has been made, the severity of the complications can be dramatically reduced with timely and continuing care, including a careful combination of diet, exercise, often oral medication and, not infrequently, insulin administration.

However, what the CDC report fails to note is that such a high level of medical attention is widely unavailable to millions of Americans, who are unable to afford health insurance. With growing poverty, increasing numbers of people cannot buy nutritious food or the glucose test strips needed to monitor sugar levels. For families working multiple jobs and handling the stress of endless financial problems, adequate exercise is also often out of reach.

The rise in the incidence of Type 2 diabetes has come alongside a decline in the overall quality of nutrition in US society and a sharp growth in obesity. These processes are bound up with subordination of the food industry to the profit motive, a fact that has even garnered attention in the mainstream press. In May 2009, the news magazine Businessweek observed that “evidence is mounting that the obesity crisis is not the result of a lack of personal responsibility,” going on to note that “the processed food industry’s practices may be just as much, if not more, to blame.”

The omnipresence in the food industry of federally subsidized corn carbohydrates and dairy fats, coupled with advertising campaigns aimed at the most vulnerable segments of the population—the young and the working poor—have been cited in studies as chief reasons behind the enormous weight gains of the American people over the last 40 years.

At the 2009 European Congress on Obesity in Amsterdam, Dr. Boyd Swinburn of Deakin University in Melbourne, Australia, pointed out to Heartwire that the food industry has been targeting the most impressionable layers of society. “They’ve worked their marketing out to the nth degree,” he noted.

In 2009, Kelly D. Brownell from the Rudd Center for Food Policy and Obesity at Yale University and Kenneth E. Warner from the University of Michigan published an article entitled, “The Perils of Ignoring History: Big Tobacco Played Dirty and Millions Died. How Similar is Big Food?” The authors noted:

“To protect profits, the food industry must avoid perceptions that it is uncaring and insensitive, ignores public health, preys on children, intentionally manipulates addictive substances, and knowingly, even cynically, contributes to death, disability, and billions in health care costs every year. Stated another way, it cannot afford to look like tobacco.”

As Brownell and Warner point out, the food industry buys access to key associations, including the professional organization for US nutritionists, the American Dietetic Association. The Association regularly publishes “fact sheets” on nutritional advice for the public. The food industry pays $20,000 per sheet, which industry lobbyists then write for the association.

According to Brownell and Warner, the food industry’s strategy for deflecting attention from its practices for the poor state of nutrition in the US includes the following:

“Focus on personal responsibility as the cause of the nation’s unhealthy diet; raise fears that government action usurps personal freedom; vilify critics with totalitarian language, characterizing them as the food police, leaders of a nanny state, and even ‘food fascists,’ and accuse them of desiring to strip people of their civil liberties; criticize studies that hurt industry as ‘junk science’; emphasize physical activity over diet; state there are not good or bad foods, hence no food or food type (soft drinks, fast foods, etc.) should be targeted for change; plant doubts when concerns are raised about the industry.”

On the very day of the CDC’s 2011 Fact Sheet release, Robert Langreth of Forbes noted that sections of the pharmaceutical and health care industry were pleased with the latest report.

“What’s bad news for Americans is good news for companies that make diabetes treatments. One company that has ridden the obesity and diabetes epidemic like no other is the Danish company Novo Nordisk…. Other companies helped by the bad news include Merck (of the popular diabetic pill Januvia), Allergan (obesity surgery supplies), Orexigen Therapeutics (new obesity drug pending FDA approval).”