Continuing our coverage of the American Diabetes Association's annual conference, we hear today from well-known Certified Diabetes Educator (CDE) and fellow diabetes advocate Hope Warshaw, who takes issue with how some mainstream media has been covering some study findings presented in Chicago.
Hope is passionate about the importance of research data for the practice of medicine, and she's also enthusiastically embraced social media.
Today she shares some thoughts about the difference between what was "covered in the news" and what was actually announced at the Scientific Sessions.
"I doubt there will be any positive results reported," I said to my colleague, as we sat at a Monday morning session at the recent American Diabetes Association's 73rd Scientific Sessions.
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This was the start of a session on a large and lengthy study known as Look AHEAD, which focused on the effectiveness of intensive lifestyle intervention (ILI) for overweight type 2s, and whether those weight loss interventions over time can prevent or delay cardiovascular complications in type 2 diabetes.
My colleague, an interventionist at one of the 16 multicenters where this NIH-conducted Look AHEAD trial happened, reassured me. "You'll be surprised," she said, and those words convinced me to sit right up front with her.
And, right she was -- I was surprised!
Unfortunately, the publication to reveal the final Look AHEAD results in print was the New England Journal of Medicine, and it didn't reflect the surprise and positivity that those of us in the audience experienced at the ADA session. Instead, it focused on the lack of effectiveness. And that's pretty much all that got headlined and reported in the news.
Yes, the usual doom and gloom about the ineffectiveness of intensive lifestyle intervention.
Intensive lifestyle intervention did not reduce CV events in overweight adults w/ type 2.
In print and online headlines, like this one in the Wall Street Journal, we saw this kind of coverage:
Disappointing Results for Weight Loss and Diabetes.
But I responded, tweeting back to @NEJM and others: Important to look at Look AHEAD data deeper. Many positive results: starting with less use of several meds.
Now, with more than 140 characters to spare, let me detail what several of the study's lead principle investigators told the ADA audience about how the trial didn't reduce cardiovascular events, yet why many positive outcomes were shown in the trial:
The leading researchers include Dr. Rena Wing from Brown University, Dr. William Knowler from the National Institutes of Diabetes, Digestive, and Kidney Disease (NIDDK), and Dr. Lucy Faulconbridge at the University of Pennsylvania. Over 5,000 patients were involved, in two groups: the 'ILI' or intensive lifestyle intervention group that was actively treated, versus a control group that received more traditional treatment with less emphasis on lifestyle changes.
Before jumping in, it's important to note that the Look AHEAD trial, which was planned for 13.5 years of follow up and was stopped after 11.5 years, is still one of the longest and largest lifestyle/weight loss trials ever conducted. And it's not over. Researchers will continue on with the work as an observational trial. I've written a recap on this research before, right after it was halted back in October 2012.
You can bet we'll see many publications with data on various topics from the trial, as well as publications from the continuing observational study period.
To date, one-year data was published in the journal Diabetes Care back in June 2007, and four-year data was published in the Archives of Internal Medicine in September 2010. I've recapped the four-year findings in a NutriZine post.
As you review these results and ongoing publications from the trial, keep in mind the researchers achieved a study population retention rate of 96%. That's huge! This means they can analyze data from almost all participants, which strengthens the value of the data.
One question on people's minds at the ADA symposium was why the study was stopped a few years early. Answer: the overseeing body for this NIH-conducted multicenter trial determined that further study of the two groups would not lead to any additional findings. So really, there was no point in continuing.
As to the why there weren't significant differences in CV events in the two groups, the presenters noted that larger weight loss in the intervention group may have been needed and perhaps the study was not long enough. Hmmm, this seems odd since the study was stopped early -- bit of a disconnect here. The presenters noted that the people in the control group experienced a greater use of LDL cholesterol-lowering statins, and possibly more intensive medical management of their CVD risk factors.
Keep in mind, people in the control group likely received more diabetes support and education than the average person with type 2. So as a group, the control diabetes support and education patients might have done better than a group of people with type 2 receiving usual care in the real world, making it more difficult for the study to demonstrate a difference.
Researchers remarked that earlier intervention may be needed. The 5,000-plus people in the trial had been diagnosed with type 2 diabetes for an average of 7 years. Personally, I hope there can and will be an analysis of what this all means relating to how long someone's been living with diabetes. This would help us learn whether that early intensive intervention can make an even bigger difference on outcomes.
What else wasn't "reported" in the first NEJM paper but was presented at the ADA sessions, relating to the study's positive results:
- Weight loss: The ILI group lost the most weight (8.6%) by the end of the first year and had some weight regain, which is exactly what we've seen in many long-term weight loss trials. This weight gain flattened out by the end of the study with a small amount of further weight loss. It was conjectured that this additional weight loss at the end of the trial could be attributed to aging. They'll be looking at whether this weight loss was more fat mass or lean body mass.
- Fitness: ILI had greater improvements.
- A1C: The greatest lowering of A1c was at one year, but the ILI group still maintained a significantly lower A1c at the study completion with less use of insulin compared to the control group. And again there appears to be some, what's referred to as, metabolic memory... the body remembers the earlier period of good glucose control. (The same phenomenon has been seen in other trial with long follow up, like the DCCT/EDIC trials.)
- Systolic Blood Pressure: Greater improvement in ILI, but not in diastolic BP. The ILI group was less likely to use anti-hypertensive medication.
- Lipids: HDL cholesterol more increased more (that's good news!) in the ILI group. LDL cholesterol decreased in both groups but the ILI group required less statin medication.
- Chronic renal/kidney disease: 31% reduction in the ILI group.
- Retinopathy: Reduced self-reported symptoms in ILI group.
- Other health related improvements in the ILI group, including less depression, sleep apnea and urinary incontinence.
And to the question, did people in the ILI group save on health care resources? The answer from Dr. Henry Glick, a University of Pennsylvania health economist and fourth speaker on the panel: YES! The trial data showed that the ILI group had reduced cumulative hospitalizations, used less medications (insulin, anti-hypertensives, statins) and generally utilized less health care services.
In my mind, the results of the Look AHEAD trial show this: keeping off a minimum amount of weight during the course of a decade after achieving significant weight loss in the first year is possible with intensive lifestyle intervention. Remember that the average American adult gains a couple of pounds per year!
Clearly, these results are quite a laundry list of positive health benefits for people with type 2 diabetes trying to get and stay healthy over the years. And it amounts to overall cost savings for our healthcare system, too!
Factoring in the full findings of this study, that's the headline I rather would've seen about this study, as we look ahead to future studies that can translate to how we work with our patients.
Thank you, Hope. It's always good to hear the "real story" from those in the know!