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Looking Back at Look AHEAD


Last week, the US National Institutes of Health (NIH) announced the discontinuation of the intensive diet and lifestyle interventions in the Look AHEAD (Action for Health in Diabetes) study.

This study, now in its eleventh year, was designed to compare the effects of an intensive diet and lifestyle program designed to promote and sustain weight loss versus ‘usual care’ on the prevention of heart attacks, strokes and cardiovascular deaths in individuals with long-standing type 2 diabetes.

The study was conducted at 16 centers across the United States included 5,145 people who were 45 to 76 years old when they enrolled in the study. Sixty percent of participants were women.

Participants in the intervention group lost more than 8% of their initial body weight after one year of intervention and maintained an average weight loss of nearly 5 percent at four years.

This reduction in body weight was accompanied by significant improvements in glycemic control and numerous other health benefits (e.g. decreased sleep apnea, improved mobility and quality of life).

However, given a remarkably low incidence of ‘hard’ endpoints in both the interventions and control groups, it became evident the the study would stand little chance of demonstrating superiority of the lifestyle intervention in terms of preventing cardiovascular complications.

These results are perhaps not all that surprising, given that recent pharmacological studies in patients with type 2 diabetes have also failed to show a significant reduction in cardiovascular deaths.

Moreover, readers may be aware that even with the substantially greater reduction in body weigh with bariatric surgery, the Swedish Obesity Surgery study, took over 13 years to demonstrate a barely significant reduction in myocardial infarcts (but not deaths!) in patients with type 2 diabetes.

In hindsight, hoping for a greater impact with diet and exercise than even that seen with bariatric surgery would seem rather optimistic (to be fair, the surgical data were not available at the time this study was planned).

Nevertheless, according to the recommendations of the Data Monitoring Board, the study should be continued (without the intervention) to determine the long-term outcomes in the participants.

While the results of this study are certainly disappointing to the researchers involved, they do provide important lessons for designing future trials of obesity treatments in patients with type 2 diabetes.

Not only may future studies have to enrol a substantially greater number of participants but such studies may also need to substantially enrich the study population with higher risk individuals to increase event rates (i.e. EOSS Stage 3 rather than just EOSS Stage 2 patients).

Obviously, the wild card here is whether or not ANY amount of weight loss will suffice to reduce mortality in a population that already has well-established heart disease (remember the obesity paradox).

Thus, whether or not weight loss (through lifestyle interventions or otherwise) will save lives in individuals with established type 2 diabetes may well, in the end, be a question, to which we will never quite know the answer.

AMS
Chicago, IL

photo credit: Môsieur J. [version 7.1.2] via photopin cc

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5 Comments

  1. Even if there doesn’t appear to be a difference in longevity there will be a difference is quality of life. Mobility, self esteem etc. I know I’ve read articles where given the choice women would give up ten years of life to be thinner. Just some thoughts.

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  2. The results are really disappointing for primary care. Many questions are now raising.

    What’s the link between risk factors and hard cardiovasculair endpoints ? Weight loss, HbA1c, lipids are they less important for CV disease in a population of 2.000 diabetics ??

    Is the introduction of a statin and ASA more important to CV disease in such a population ?

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  3. Yes, these results are disappointing. At least it’s now demonstrated that long term weight loss can be achieved among diabetics without obesity drugs or bariatric surgery (even with moderately low fat diet). I wonder why there were no differences in LDL levels (according to HeartWire news)?

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  4. Let’s look at the cost of medications–many overweight people get there meds covered by the government–would not a reduction of just one medication be enough to justify the cost of intensive intervention; even long-term intervention. One form of money to prevent a heart attack that would be more expensive then the lifestyle intervention would be.

    Intervention does make financial sence from my veiwpoint. And when you consider that I am not university educated that says something.

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  5. Let’s compare the cost of one day in ICU to that of a once a month diatition and GP visit the ICU would be the result of a heart attack where as the diatition and GP would be the result of intensive intervention. The cost difference is over whelming to say the least. Therefore, I do not believe that more studies are needed just maore people taking the intensive intervention. Fairly good economics.

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