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Look AHEAD Study--"Negative Result"
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Michael Dansinger, MD posted:
The Look AHEAD study tested the effectiveness of lifestyle coaching (caloric reduction and increased exercise) and weight loss (compared to a usual care control group with no weight loss) for reducing rates of cardiovascular events in overweight patients with type 2 diabetes over the course of up to 11 years.

The study was halted last week--two years early--because there was no difference in cardiovascular events between the lifestyle coaching group and the usual care control group.

I was surprised because I was fairly confident that the long-term weight loss (5% of initial body weight--around 10-12 pounds) over 5-10 years in most participants, would translate into delayed onset or prevention of cardiovascular events compared to the control group.

It is still hard for me to know what to make of this unexpected and disappointing result. Once more information about the results becomes available it may become easier to draw some useful conclusions.

I think it would be a mistake to conclude there is no point to making an effort to eat right and exercise. I believe patients in the lifestyle coaching group did not require as much medication as the control group, and they may have had many real health benefits and improved quality of life on many fronts. I must also wonder whether an alternative dietary approach or an even more intensive approach would have made the difference. We will learn more once we have a chance to "study the wreckage" of this disappointing study result. I really wish it had proven that we can prevent heart disease and cardiovascular events in such patients. In the meantime I will continue to believe that lifestyle change can make a tremendous difference for patients once we learn to fully harness its power.

Michael Dansinger, MD
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Michael Dansinger, MD responded:
For those who want to learn more about the Look AHEAD study and why it was halted, I've pasted the commentary from one of the lead study investigators:


http://www.medscape.com/viewarticle/772429?src=mp

Hi. I am Dr. Anne Peters from the University of Southern California, and I am here today to discuss why the Look AHEAD trial was stopped. I am one of the principal investigators of the Look AHEAD trial, so I know the trial pretty well. From my perspective, it has been a very interesting study, and I think that we have interesting findings to come that may not be reflected in what has been learned recently.
The Look AHEAD trial looked at the benefits of weight loss and exercise in the treatment of type 2 diabetes.[1> I can tell you from the outset that we were successful. We got our patients to lose weight, increase their physical activity, and do it over a long period of time -- for up to 11 years. I think that is important: We were able to reach our lifestyle goals. But the primary outcome of this study was a macrovascular event outcome. It consisted of nonfatal myocardial infarction, nonfatal stroke, death, or hospitalization for angina. In terms of the primary outcome, we did not see a difference between the 2 groups at 11 years.
Overall, the rates of cardiovascular events and death were actually quite low in both the intervention group and the control group. We did not see a difference in the lifestyle arm even though they did better in terms of weight loss and increased physical activity. There was, however, only 1 outcome. I believe that there are many other outcomes that people derived along the way from losing weight and becoming more physically active. For instance, we know that rates of sleep apnea were lower in the group that was intensively treated. We know that patients had lower rates of urinary incontinence and they were on less medication. There are many things that we need to analyze further in order to fully look at the benefits of weight loss and exercise in this population, but we do know that they did not improve the 1 big macrovascular primary outcome. We also need to look at subsets; there may be people who did better or worse in terms of responding to the intervention. All of these analyses (although I want them all done right away) have not been finished yet. I think that there is a lot that we have to do to truly look at all the benefits and risks of a lifestyle intervention. Those are the headlines. Let me go into the details to explain a little more.
 
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Michael Dansinger, MD responded:
Continued from above:

This study consisted of 5145 adults with type 2 diabetes who had a body mass index (BMI) > 25. They were overweight when they came in to the study and were randomly assigned to the intensive lifestyle arm or the diabetes support and education (DSE) arm, which was, in essence, the control group who were given education and meetings twice a year, but they were not given the intervention that we provided to the lifestyle group. The intensive lifestyle group had a wonderful intervention: They were given individual sessions with a nutritionist and/or a trainer, they had group sessions, they had refresher courses, and they were given all the tools they needed to really work on and succeed at their lifestyle intervention. I think our patients did a fantastic job, and we were able to see an 8.6% reduction in body weight in the first year. That was not entirely sustained. During the next year, that weight loss changed to only about 5% of their body weight, but that was maintained through the duration of the trial to 11 years. We were able to show that we could produce modest weight loss and improve physical activity over time in these individuals with type 2 diabetes. However, what we did not show was a reduction in cardiovascular events and death.
When you start talking to your patients about this trial, it does not mean that they should go out and eat anything they want and stop exercising. Again, there are real benefits to lifestyle change. Patients in the control group, the DSE group, did not gain weight. In fact, they slightly lost weight over time, so these patients weren't out there doing nothing. They were actually doing a little bit and minding their health. Moreover, patients in both groups started out better in terms of their control than many of our patients. The average A1c level was 7.3% at the beginning of the trial. LDL cholesterol was 112 mg/dL, they had reasonable blood pressures, and their BMI was about 35. These were not terribly out-of-control patients. Some were, but on average they were a pretty well-controlled group going into this study.
We do know that weight loss and exercise can prevent diabetes. I am a big advocate of prevention, both early prevention of obesity altogether, as well as prevention of diabetes in individuals who have become overweight. Lifestyle changes can help prevent diabetes. Once you have diabetes, I think weight loss and exercise can have benefits, but they are not going to reduce the risk for the primary outcome that we set for Look AHEAD, which was a risk for macrovascular events or death. I think it is important to help put this trial into perspective for patients. Look AHEAD will now change into a cohort study in which we follow patients over time. There will be a lot more data coming from Look AHEAD that can be interpreted in the future.
This has been Dr. Anne Peters for Medscape. Thank you.
 
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flutetooter responded:
WOW! I still refuse to give up my 1/2 cup of frozen plain 0% fat Greek yogurt with unsweetened cocoa powder which I call "icecream. lol That's probably why my cardiologist (for bradycardia - no symptoms) laughed when I told him how I controlled my blood sugar by counting carbs and exercising. Sad study conclusion indeed.
If at first you don't succeed, try, try again!
 
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mhall6252 replied to Michael Dansinger, MD's response:
Wow! More than 5000 patients over 11 years - it's not a small study group. I'm sure the medical community finds this disappointing. And how do you argue with patients who would say "what does it matter?" Unless feeling better, in general, is taken into account.

And what about people whose BMI was only slightly high - did lifestyle changes make a difference for those folks?

What about people whose A1c approached double digits? Did they benefit?

Lots of questions, for sure.
Michelle
Diabetic since 5/2001
Follow my journey at www.mch-breastcancer.blogspot.com
Smile and the world smiles with you.
 
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brunosbud responded:
like finding true, lasting love or raising children you can be proud of, people think good health (or avoiding a "macrovascular event") is a matter of "luck"...

Sorry, but "luck" aint got a damn thing to do with it. Not in these days...
 
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Haylen_WebMD_Staff replied to mhall6252's response:
Michelle - My first thought was a point you brought up. Hoping that those striving for better health don't see this as a "give it all up" moment. The benefits of weight loss and increased exercise are so great!

I wonder why "feeling better" isn't a big enough payoff to live a life of eating healthy food and portions and getting exercise?

Haylen
 
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flutetooter replied to brunosbud's response:
To bruno, To whom are you attributing the conclusion of "luck"? the doctors?, the study?, the diabetic patients? I am sure that all diabetics on this diabetic exchange think that what they and their doctors do to control diabetes is much more than luck
.
If at first you don't succeed, try, try again!
 
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auriga1 replied to mhall6252's response:
Michelle, you are so right about the feeling better statement. Who wouldn't want to feel better all the time? Lifestyle changes surely manifest into "feeling better."

Very interesting results. Thank you to Dr. Dansinger for letting us know.

Cardiovascular disease runs in my family. There is no obesity or even slightly overweight in the family members. This is on my mom's side along with the diabetes.
 
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Warshaw replied to Michael Dansinger, MD's response:
Dr. Peters -
Thanks so much for being an investigator in this important Look AHEAD study and for taking the time to write your valuable comments. As a dietitian/diabetes educator who has been following the Look AHEAD trial and someone who has talked with colleagues who are on the front lines of this trial, I think there are a number of positive findings.

I've just posted a blog which summarizes the study and a few take aways: http://hopewarshaw.com/blog/let%E2%80%99s-look-ahead-look-ahead

Thanks,
Hope Warshaw, MMSc, RD, CDE
 
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betatoo replied to Michael Dansinger, MD's response:
Interesting that your control group was educated, and had meetings twice a year about diabetes. Hmmm so even the control group could have had positives after education and meetings where they understood their disease better. Wonder how that compares with regular population where no intervention is done for BMI >25. I have never attended a meeting for the disease, never had a nutritionist, only a dr that said cut white. Could heightened awareness affected the study?


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