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Surprise Ending: Huge Diabetes Study Stops Early


For overweight or obese patients with type 2 diabetes, the oft-repeated advice is to get some exercise and lose some weight to lower the increased risk of heart disease.

But a large federal study designed to prove this advice really works has ended early because weight loss and moderate exercise didn't have the expected benefit.

Details of the massive study have yet to be published, but the National Institutes of Health (NIH) pulled the plug on the study two years ahead of schedule after the rate of heart attack, stroke and cardiovascular death was identical for subjects who lost weight and those who didn't, the New York Times reported.

A statement by the NIH said the 11-year study "did no harm, but did not decrease occurrence of cardiovascular events, the primary study goal."

David Nathan, M.D., a principal investigator and director of the Diabetes Center at Massachusetts General Hospital in Boston, was blunt about the outcome: "We have to have an adult conversation about this," he told the Times. "This was a negative result."

The study enrolled 5,145 overweight or obese adults, ages 45 to 76, with type 2 diabetes and randomly assigned them to either a diet-and-exercise regimen or to sessions that provided diabetes support and education.

The diet group did lose weight - about 10 percent of total body weight in the first year, though backsliding a bit by year four - for an average loss of 5 percent of body weight during the study. That modest weight loss was enough to provide some health benefits, participants reported, including improvements in sleep apnea, mobility and quality of life. The participants were also able to decrease some of their diabetes medications.

But apparently a 5 percent weight loss wasn't enough to decrease the rate of heart attack and stroke. There was no difference between the diet group's rate and that of the diabetes-education group, who lost only about 1 percent of their body weight.

About 24 million American adults have type 2 diabetes, including 11 million 65 or older, according to the NIH. Heart disease is the most common cause of death among diabetics.

There is one thing to learn from the halted study, however, Nathan said - namely, that the dieters had about the same cholesterol, blood sugar and blood pressure levels as the control group, but they ended up using fewer medications to control their disease. Fewer medications mean fewer side effects and lower cost.

"That may be the choice we are highlighting," Nathan told the Times. "You can take more medications - and more, I should say, expensive medications - or you can chose a lifestyle intervention and use fewer drugs and come to the same cardiovascular disease risk. Those are real choices."

In other health news:

Death toll in meningitis outbreak rises to 23. Reuters reports that the U.S. death toll from fungal meningitis linked to potentially contaminated steroid injections has risen by two, to 23, with North Carolina reporting its first death, health officials said on Saturday. Tennessee's death total in the outbreak rose to eight, the highest state total, the Centers for Disease Control and Prevention (CDC) noted on its website.

Photo: helloitserica via flickr

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