Bad news for diabetics trial ends early due to no benefit

In a disappointing development for patients with type 2 diabetes and their doctors, researchers have pulled the plug two years early on a large federal study examining whether diet and exercise can prevent heart attacks and strokes in overweight and obese diabetics. The intensive intervention just was not having the desired beneficial effect on cardiovascular outcomes.

After 11 years, it became evident that the 5,145 participants in the study had nearly identical rates of stroke, heart attack and cardiovascular death, regardless of whether they were in the group randomized to receive a diet and exercise intervention, or the control group who received usual care. The study was led by Rena Wing of Brown University s medical school.

The researchers say the modest effects of diet and exercise may have been swamped by the role of smoking cessation, cholesterol-lowering statins and blood pressure medication. The dieters used fewer such drugs, which was one clear benefit of being in the study group.

ACSH s Dr. Ruth Kava says one important factor in the lack of benefit may have been patient compliance. When people are out in the population and not under strict medical supervision, it s not clear how well they follow a diet and exercise regimen, she says.