Bariatric Times

MAR 2017

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

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14 Interview Bariatric Times • March 2017 those with a BMI greater than 35kg/m 2 , BMI did not make the d ifference in terms of achieving remission. Our data certainly supports that people with BMIs 35kg/m 2 and below with T2DM have the same chance for improvement, p rovided they lose an adequate amount of weight, whether with surgery, weight loss devices, and/or pharmacotherapy and behavioral changes. As an endocrinologist, what do you find most impactful about the STAMPEDE trial's final results? Dr. Kashyap: We've known all along that if you can help people lose at least 5 to 10 percent of their body weight, you can improve diabetes. What surgery shows us is that in the setting of early duration of disease, when you get people to lose a lot of weight—at least 20 to 25 percent of their body weight— you can put the disease to rest for up to five years without needing medication, especially insulin, which is very burdensome and can cause weight gain and low blood sugar. To me, this is the most innovative finding and the greatest takeaway of STAMPEDE. I was also pleased that the trial showed 1) quality of life improvement and 2) reduction in medications needed for blood pressure and cholesterol in patients following surgery. As a medical doctor, I am still concerned about weighing the risks and benefits of surgery. In the risk/benefit equation, it's important to consider the rate of reoperation, nutrition problems (e.g., anemia), osteomalcia/osteoporosis, and late complications, such as bowel obstructions, strictures, and fistulas. All of these risks make medical doctors and patients weary of surgery. In some cases, patients may be trading in one problem (e.g., T2DM) for another (e.g., gastric ulcer) related to undergoing abdominal surgery. That risk/balance equation has to be individualized and carefully discussed because although the benefits are definitely there for surgery, it is still surgery and a lot of patients aren't ready for it. In my practice, most patients with BMIs under 35kg/m 2 are not really interested in surgery. If they are 30 to 40 pounds overweight, t hey would much rather try nonsurgical means before considering surgery. I find that patients are aware of the comorbidities of overweight and o besity and understand that they really impact their health and life. There are still people out there with very high BMIs who are not getting surgery that could benefit from it. I t hink although our results show there may be similar benefits for people with BMIs under 35kg/m 2 , the focus should still be on people with higher BMI as the public health need is still great for this patient population. What do you think about nonsurgical devices as a means for treatment in patients with BMIs 35kg/m 2 and below with T2DM? Dr. Kashyap: I I think things like the intestinal liner, intragastric balloons, and any other device or therapy that helps people lose weight, especially when their diabetes is fairly early, is going to result in some improvement if not remission. The big question we haven't answered yet is exactly how much weight do people need to lose to get into T2DM remission? Is it 10 percent of your body weight? 15 percent? What is the magic number? I think it would be good to know. It would also be good to know the etiology of weight regain so we can determine the best means of intervention. Sometimes weight regain is related to life stressors or depression, in which case a patient might benefit from being referred back to the psychologist or dietitian. A multidisciplinary approach after surgery, and after they achieve remission, is often necessary. Do you feel endocrinologists are now more aware of the benefits of bariatric surgery? Dr. Kashyap: Absolutely. I think that endocrinologists are now being trained at most of the national meetings—ADA, Endocrine Society. There are always talks about bariatric surgery—how to manage the post bariatric surgery patient, how to deal with weight regain, and b arriers to care. What are examples of barriers to care? Dr. Kashyap: F irst, I think it's the patients themselves that create barriers to their own care. A patient has to be willing to consider treatment, including surgery. As m entioned previously, I find that patients have a real fear of having a permanent, irreversible surgery. It means changes in the way they eat and behave, which is a scary thing for a majority of patients. It requires a lot of thought. The patients are their own worst enemy. We are the ones that really try to counsel them. For example, I talk to them about durability. When a patient expresses that they want to try diet, behavior modifications, and pharmacotherapy, I help them to manage weight loss expectations for each therapy. For instance, with the diet and pharmacotherapy, they will likely be able to lose 10 to 12 percent of body weight, but this is a huge difference compared to the 25 to 30-percent weight loss they would likely be bale to achieve with bariatric surgery. Next, there is a barrier in referring patients for surgery, which is mostly due to insurance coverage and financial issues. With the STAMPEDE trial completed, what is the next area of research in which you are applying your focus? Dr. Kashyap: Unfortunately, our study was too small and we did not see any changes in the rate of retinopathy, nephropathy, or any other complications of diabetes. We didn't see any changes in renal function or retinopathy, which is what most endocrinologists want to see. So, the next big question is, "Can bariatric procedures affect end organ damage related to diabetes?" I am currently involved in the Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D). Through this project, we will examine data from four sites— Cleveland, Ohio, Pittsburgh, Pennsylvania, Seattle, Washington, a nd Boston, Massachusetts. This project is valuable because it will give us a larger sample size— around 300 patients. You can learn more about ARMMS-T2D at h ttps://clinicaltrials.gov/ct2/show/N CT02328599. Do you have any final words about the STAMPEDE trial's final results? Dr. Kashyap: I think these data are really important. The fact that you can see durability of results t ells me that metabolic surgery is here to stay. Endocrinologists as well as other members of the multidisciplinary care team should continue to work closely with s urgeons to try to optimize weight loss and T2DM outcomes in patients. Editor's Note: Article c ontaining full STAMPEDE Study results were in press at the time this interview was conducted. REFERENCES 1. Schauer PS. American College of Cardiology's 65th Annual Scientific Session. Chicago, Illinois; April 2–4, 2016. 2 . Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes - 5-year outcomes. N Engl J Med. 2017;376(7):641-651. 3. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366(17):1567– 1576. Epub 2012 Mar 26. 4. Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes—3-year outcomes. N Engl J Med. 2014;370(21):2002– 2013. Epub 2014 Mar 31. FUNDING: No funding was provided in the preparation of this manuscript. FINANCIAL DISCLOSURES: The author reports no conflicts of interest relevant to the content of this article. ADDRESS FOR CORRESPONDENCE: Dr. Sangeeta Kashyap; E-mail: Kashyas@ccf.org We've known all along that if you can help people lose at least 5 to 10 percent of t heir body weight, you can improve diabetes. What surgery shows us is that in the s etting of early duration of disease, when you get people to lose a lot of weight—at l east 20 to 25 percent of their body weight—you can put the disease to rest for up to five years without needing medication, especially insulin, which is very burdensome and can cause weight gain and low blood sugar.

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