July 9th, 2013

Look AHEAD: More Questions Than Answers

Lifestyle approaches have long been the cornerstone of diabetes care. The diabetes epidemic has been driven largely by increasing obesity and changes in lifestyle; it follows logically that changing lifestyle should prevent and treat diabetes. Indeed, we know that lifestyle interventions reduce weight, improve well-being, decrease risk of diabetes, and can sometimes lead to remission of type 2 diabetes. However, it has been unclear whether lifestyle interventions for weight loss actually reduce cardiovascular events, the leading cause of morbidity and mortality in type 2 diabetes.  The Look AHEAD study examined this very question and found that an intensive lifestyle intervention led to greater weight loss compared with a conventional diabetes support and education strategy among overweight or obese patients with type 2 diabetes, but did not result in a reduced rate of cardiovascular events. What do these findings mean for patients and health care systems?

First, should we hold lifestyle interventions to the same high standards of scrutiny as pharmacological interventions?  It’s true that the primary outcome was negative, but there were many secondary outcomes that improved with the lifestyle intervention. This type of evidence should not be sufficient to approve a new drug, but isn’t it enough to promote changes in lifestyle? The safety of lifestyle interventions seems relatively well established. In fact, there seems to be little downside to encouraging diabetes patients to embark on an intensive lifestyle plan aimed at weight reduction. But, despite the fact that lifestyle interventions are overwhelmingly safer and less likely to result in adverse effects than are medications, there are potential downsides. We have to be fairly confident that lifestyle interventions are worth the cost, effort, and burden they impose – and this requires that we hold them to a relatively high standard when we evaluate their impact.

Second, don’t we already have enough evidence about the impact of lifestyle interventions to implement them in care? I admit that I am still enthusiastic about promoting lifestyle changes for my diabetes patients despite the fact that the primary outcome of the large, well-designed, long-term randomized controlled trial was negative. To me, this suggests that the trial may not have a huge impact on clinical practice – we already know that losing weight and exercising is good for health. Alternatively, I may be experiencing cognitive dissonance and unwilling to admit it!

The third question I will leave up for debate. I may be convinced about the benefits of lifestyle interventions, but will health care systems be willing to pay for them given the results of Look AHEAD?


6 Responses to “Look AHEAD: More Questions Than Answers”

  1. Venkatesan Sangareddi, MD.DM says:

    Look AHEAD and feel depressed about this shocking study !

    Life style modification is the key to prevent major diabetic and cardiac events . This is well proved beyond doubt.

    Epidemiological evidence from various global health statistics accumulated over a century will vouch for this .Even primary prevention of diabetic and cardio vascular disease is possible .

    I argue the medical fraternity and patients to ignore this study . It can be convincingly concluded something is seriously wrong with the outcome analysis , however modern may be the statistics. Some groups are obviously worried about the natural and effective control of diabetic by good life style alone . It is a clear case of confusing the public .

    There is huge collective evidence (and common sense ) for the increased physical activity to reduce cardio vascular risk (INTERHEART)

    If life style modification is not going to help , What is the alternative to our patients ? Drugs . . . yes . . . one has to depend on it . . . this study seems to suggest .

    To me , this is a dangerous study . It plays a spoil sport on a great fact and belief . This paper should never have been appeared in a journal like NEJM . Atleast the conclusion should have been re-written !

    I guess there is a hidden agenda . Some mysterious forces want the Homo-sapiens inactive and make them diabetic and consume drugs perennially !

    Dr Venkatesan Sangareddi MD
    Associate Professor of cardiology
    Madras Medical college

  2. Björn Hammarskjöld, M.D., Ph.D. says:

    It is interesting as usual.

    First, there is no definition of a healthy lifestyle.

    Second, we have tried to eat less and run more for three decades. It seems to be a non-working approach as the results seem to increase the frequency of obesity and diabetes.

    Third, all metabolic approaches are the same:
    A. Famine with 800 kcal/day including 50 % carbohydrates = 100 g of carbohydrates per day.
    B. Low carb diet with 2,500 kcal/day with 16 E% of carbs = 100 g of carbs per day.

    Results: Method A gives a weight reduction as big as method B.
    Both methods are lifelong working.

    Method A will kill you by famine within several month of severe hunger.

    Method B will keep you alive, healthy and satified for several decades.

    We have forgotten the several millennia old method to keep persons with carbohydrate metabolic disease alive.

    Fried fat pork with heavy cream stewed cabbage.
    It’s a low carbohydrate diet.

    It has been working for millennia but not for the last three decades as all persons with diabetes or obesity are supposed to eat the very same extremely high carbohydrate diet as “healthy” people are recommended to eat.
    This modern diabetic diet with 480 grams of carbohydrates per day requires a lot of drugs to keep the patients with diabetes alive.

    It’s equivalent to recommend a person with peanut allegy to have more peanuts as there are drugs to keep a person with mortal peanut allergy alive.

  3. Anil Virmani, MD, DRM says:

    We should accept this study at face – value. If, this was a drug, it would never have been approved. However, according to conventional wisdom we all know the immense benefits of LSM. Unfortunately, the reality is different ! Neither LSM produces long-term sustained benefits, nor does it have a universal applicability. Having said that, we should continue to enforce LSM , atleast for other benefits and more important better quality of life.

  4. Tina Dobsevage, MD says:

    As I recall the duration of the study was no where near long enough to draw the conclusions it did. Look at what happened in Cuba at the height of the blockade. LSM should not be modifications but rather life style from prenatal care on. A healthy lifestyle in societies where the food and beverage (including alcohol) industries market heavily and produce high calorie products of dubious nutritious value and where activity has been reduced drastically by technological innovations is not easy to achieve. In addition agribusiness has contributed to the deterioration of the food supply. I agree with Dr. Sangareddi that there is no question about the value of healthy food and daily activity. An earlier study, the Diabetes Prevention Trial showed that lifestyle changes to better food and increased activity bested metformin in diabetes prevention.

  5. Enrique Guadiana, Cardiology says:

    The study designs is minimalistic. The conclusion that intensive life intervention didn’t make any difference in the rate of cardiovascular events is misleading. The authors didn’t make any effort to evaluate adhesion or mention how many patients achieve the recommended goals of diet and exercise in the intensive lifestyle intervention..

    In a case that is possible to reach a conclusion it would be: Obese patients with type II diabetes can not maintain lifestyle changes for long periods of time. This is the issue we must address. Why our patients can’t maintain healthy lifestyle for long periods of time? Maybe this not a consequence but a very important contributor in the etiology of the disease.

  6. Alexander Madaus, MD, phD says:

    I’m very disappointed by the study design and the provided information about the actual interventions. Obviously there was a broad range of possibilities of intervention on diet (including formula diets), so it’s the usual lack of a working regimen.

    I’m also very alarmed by the fact, that such weak analysis and such a dramatic conclusion is published like this by an important source of medical information like the NEJM.
    I’m missing e.g. a subgroup-analysis of the correlation of the grade of obesity and the specific outcomes. I also miss a sufficient documentation of the medications and also based on that a subgroup analysis. And what about Albuminuria over the course of the study?

    I completely agree with Dr. Guadiana: the only conclusion is, that the lifestyle intervention failed. Due to the short duration of the effects of the lifestyle intervention the outcome is not surprising.
    Shouldn’t we look at intervention itself and determine, where we need to improve? I think, that would be a better approach to this problem.