Deaths Partially Halt Diabetes Study

The 10,000-patient study, dubbed ACCORD, was supposed to answer a big question: Could pushing blood sugar to near-normal levels, below today's recommended target, help protect these high-risk patients' hearts(2)?

Instead, the National Institutes of Health took the rare step of halting part of the study 18 months early — citing 257 deaths among aggressively treated patients compared to 203 among diabetics given more standard care.

That translates into an extra three deaths for every 1,000 participants per year, and researchers were at a loss to explain why. Diabetics' blood sugar wasn't too low, a condition known as hypoglycemia. And a close look at the multiple medications patients used, including the drug Avandia that is suspected of being heart-risky, showed no sign that any were to blame.

Ironically, the study's death rate was well below what doctors usually see in Type 2 diabetics, probably due to the extra care and monitoring they received as part of the research.

Moreover, the aggressively treated patients suffered about 10 percent fewer heart attacks overall than their counterparts, said Dr. William Friedewald of Columbia University, who helped monitor the study.

"However, it appeared that if a heart attack did occur, it was more likely to be fatal" in that group, Friedewald said. "In addition, the intensive treatment group had more unexpected sudden deaths, even without a clear heart attack."(3)

So for now, the NIH's message: Diabetics with heart disease shouldn't strive for near-normal glucose, but to a level long described as optimal for all diabetics — around 7 on a measurement scale known as the A1C.

"We obviously were surprised. We were hoping for a positive outcome, but the reason we do this research is we don't know that," said study researcher Dr. Hertzel Gerstein of Canada's McMaster University.

The findings contradict previous research suggesting that the lower diabetics can make their blood sugar, the better(3). That had specialists cautioning Wednesday that it's too soon to know if the finding among heart patients was a fluke, or a real sign of how exquisitely tailored to each patient's risk factors diabetes care must be.

Some 21 million Americans have diabetes, meaning their bodies can't properly regulate blood sugar, or glucose(1). Diabetics already are at increased risk of heart disease. Type 2 diabetes, the most common form, is linked to obesity(4), which in turn harms the heart. Plus, high blood sugar over time damages blood vessels. (5)

The A1C test tracks average glucose levels over two or three months. People without diabetes have A1C levels as low as 5.

The American Diabetes Association has long recommended that diabetics aim to get their A1C level below 7, far below the long-common 8 or 9. Every point-drop lowers the risk of serious complications, such as blindness or kidney failure(6), by 25 percent to 40 percent.

Getting too far below an A1C of 7 is very difficult, (6)and very few patients outside of research studies succeed. The NIH study aimed to have aggressively treated patients dip below a level of 6, into near-normal range. Only half got below 6.4, compared to an A1C of 7.5 among study volunteers getting standard treatment.

Wednesday's announcement does not change that guideline. Rather, the NIH's National Heart, Lung and Blood Institute added the nuance that diabetics with heart disease stop at a level of 7 rather than dip below, while researchers try to figure out what happened. They have switched all the study participants to standard therapy, and will track their health until June 2009.

Notes:

1. Type 2 Diabetes is a metabolic disorder, in which after many years of improper diet and exhaustion of the pancreases' excreted digestive enzymes; causes the pancreas to create extra beta cells in the islets of Langerhans, and secrete even more enzymes and hormones at a faster rate. Now when you eat anything, since you lack basic digestive enzymes, your pancreas secretes excess insulin hormone. This sets up a pattern in which even more insulin hormone gets secreted when you eat. This is why, by the time you have symptoms of diabetes and get diagnosed it becomes and uphill battle even when you eat properly but do not replace the necessary digestive enzymes.

2. This is a common thought process in medicine today: Just because we can, we should. Drug companies in an effort to sell more drugs, convince doctors to keep patients levels (think blood pressure, cholesterol, etc..) and an artificial low. Artificial lows are blood levels that never occur in a healthy human without medication. These low levels go against decades of former medical research and common sense and as this study proves have unknown consequences.

3. Insulin is a hormone. As a hormone, by itself ,without all balancing cofactors in the body, is: inflammatory, forces adipose tissue to make fats-causes quick and long term weight gain, forces of protein degradation, inhibits amino acid absorption, forces cells to increase sodium uptake, causes fatty liver and liver toxicity, causes arterial walls to constrict. If these factors are not a recipe for a heart attack, I don't know what is.

4. This is a case of which came first the chicken or the egg. See No.1, above. The long term eating disorder, followed by metabolic changes, causes diabetes. Being overweight does not cause diabetes. Eating wrong does. This is why type 2 diabetes can be diet controlled.

5. It is actually the long term use of extra insulin that causes heart disease, not high blood sugar. This is a common misconception.

6. This fact is very hard to prove. To get a diabetics A1C below 7 the average diabetic overshoots insulin and eats all sorts of NutraSweet or Splenda laden pseudo foods. It would be hard to prove any reduction. Today's diabetic's consumption of NutraSweet (mainly) and Splenda causes kidney disease, which causes high blood pressure, which can cause arterial and heart disease. On a side note, today's common progressions of diabetes: heart disease, coronary hear disease, kidney failure, neuropathy, eye disease, and vascular disease; were uncommon in diabetics before the wide spread use of NutraSweet in sugar free foods. All of these symptoms are well known symptoms of Aspartame overload. Now these long term toxicities are considered part of the disease. Think of it! GD Searle (Drug Company-FDA rejected it at first due to great link to brain cancer) creates NutraSweet and drug companies have been reaping billions in long term diabetic care and treatment of advanced disease.