Thursday, July 11, 2019

Retrospective #145: Gastric Bypass vs. Medical Therapy

Recently, my Medscape alert brought me a story on “Gastric Bypass vs. Conventional Medical Therapy for Metabolic Syndrome.” I read it, and the full paper in JAMA, and my reaction was that it would be funny if it weren’t so very sad. This study used a “2-group unblinded randomized trial” and is a perfect example of how bloody blinkered the medical community is to the treatment of Metabolic Syndrome and its associated co-morbidities.
This narrow mindedness is best demonstrated by the first bold heading in the abstract: “IMPORTANCE: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown.” Unknown!!! Let’s face it. This naïve statement is just a set-up to obfuscate and camouflage the true purpose of the entire enterprise: to promote gastric-bypass surgery in “mild to moderately obese patients with Type 2 diabetes.” Generally gastric bypass is reserved for the morbidly obese patient (BMIs ≥ 35). The growing number of gastric bypass surgeons, however, requires that there be more “eligible” patients. And the sooner the better, before the unfortunate side effects such as “dumping episodes” and a higher suicide rate are better known. 
Controlling glycemia, blood pressure, and cholesterol are certainly important for patients with diabetes. How best to achieve these multiple goals (collectively known as Metabolic Syndrome), is certainly, however, NOT UNKNOWN. It has been documented innumerable times in countless papers published in the peer reviewed medical literature. The problem is that control is NOT ACHIEVED with “medications for hyperglycemia, hypertension and dyslipidemia (that) were prescribed according to protocol” nor with “surgical techniques that were standardized,” to quote from the specific “interventions” utilized in this trial. Control is achieved by what type of food you eat.
This study had a “lifestyle modification” component modeled on recent “successful clinical trials, they said, particularly the “Diabetes Prevention Program” and the “Look AHEAD Protocol.” The interventions in those trials were to lose 7% of body weight and to exercise 150 minutes (!) a week. The Look AHEAD Protocol also examined whether weight loss reduced the risk of heart attacks and strokes in obese Type 2 diabetics. It did not.
Maybe (Is my sarcasm too thick?) the problem with these studies is what they have in common- a “healthy low-calorie, low-fat diet” that fails to lower blood glucose enough to reduce the risk of diabetic complications, including heart disease. The lifestyle intervention protocol in this trial was similar for participants in both treatment groups.
In the Gastric Bypass study protocol, “Portion controlled diets using meal replacements, structured menus, and calorie counting…encouraged to help participants stay within calorie limits.” “Both groups met regularly with a trained interventionist to discuss strategies for facilitating weight management and increasing physical activity. Topics included self-monitoring, stimulus control, problem solving, social support, cognitive behavior modification, recipe modification, eating away from home, and relapse prevention.”
Maybe I am being too hard on these gastric bypass surgeons. Study participants were, after all, a “failed” cohort. Participants had diabetes for an average of 9.0 years, had a mean BMI of 34.6, and a mean A1c of 9.6%, in spite of medications to control diabetes and cardiovascular disease risk factors (statins). Perhaps I should ignore the fact that the Principal Investigator, or PI, who created the study concept and design, drafted the manuscript, and provided study supervision, received funding for the study from Covidien, a leading manufacturer of surgical devices, as well as serving on the medical advisory boards of Novo Nordisk, USGI, and Medica. Eight other co-authors, all doctors and support staff, also reported receiving grant support from Covidien, including one who received salary support for what, in small print, is called, unabashedly, “The Diabetes Surgery Study.” 
I can ignore these funding facts, just as they ignore an effective dietary therapy for hyperglycemia (carbohydrate intolerance). To achieve control, you need to eat fewer carbs. As your weight drops your blood pressure and cholesterol will improve too. Your weight is under your control because what you eat is under your control.

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