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Results Rolling in for Look AHEAD Research Group

Researchers have published their findings from the NIH-sponsored Look AHEAD clinical trial in three areas relevant to type 2 diabetes management.

For the last 13.5 years, the NIH-sponsored Action for Health in Diabetes (Look AHEAD) clinical trial has followed overweight volunteers with type 2 diabetes while encouraging weight loss through decreased caloric intake and increased physical activity.

Now, the researchers behind those studies have published their findings concerning three areas relevant to diabetes management:

  • In their “Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes” study published in the New England Journal of Medicine, the investigators examined whether an intensive lifestyle intervention designed to achieve weight loss through caloric restriction and increased physical activity reduces mortality and morbidity — a question that has never been answered definitively. Although patients in the intervention group lost more weight — approximately 6 percent compared to 3.5 percent in the control group — and tended to maintain that loss, at a median follow-up of nearly 10 years, the two groups had no significant differences in cardiovascular morbidity and mortality. The study ended early due to futility analysis, meaning there was a probability that continuing the study would not result in a statistically significant difference, and the authors looked for reasons that the expected result, meaning less morbidity and mortality in the control group, was not demonstrated. They suggested that patients may need to lose more than 6 percent of their bodyweight in order to reduce adverse outcomes, or that the difference between the treatment and controls groups was insufficient to create a difference.
  • In a study published in Diabetes Care, researchers used the Look AHEAD study group to examine the effects of intensive lifestyle intervention on sexual function in women who had type 2 diabetes — a group that often experiences the problem. Fifty percent of the women (n=375) enrolled in the study reported sexual dysfunction. At the study’s conclusion, intensive lifestyle intervention seemed to be beneficial, especially in women who reported sexual dysfunction at the start of the research project.
  • A third study published in Sleep looked at intensive lifestyle intervention and the effect of weight loss on sleep apnea. After studying patients over a period of four years, the authors found that an initial weight loss improved sleep apnea, and the improvement was sustained over four years for most patients — even those with an average weight regain of roughly 50 percent.

Despite the negative findings of the first study, intensive lifestyle intervention was deemed to be associated with numerous benefits that improve quality of life. Additional findings in several other areas are currently being published.