Recently, my Medscape alert brought me write-up by Albert B. Lowenfels, MD: “Gastric Bypass vs. Conventional Medical Therapy for Metabolic Syndrome.” I read it, and the in JAMA, and my reaction was that it would be funny if it weren’t so very sad. This study uses 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 exemplified by the first bold heading in the abstract, quoted here: “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 “innocent” statement is just a set-up to obfuscate and camouflage the true purpose of the entire enterprise, which is to promote gastric-bypass surgery in “mild to moderately obese patients with type 2 diabetes.” Gastric bypass is generally reserved for the morbidly obese patient (BMIs ≥ 35). The growing number of gastric bypass surgeons, however, necessitates 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 is certainly important for patients with diabetes. How best to achieve these multiple goals (collectively known as ), is certainly, however, NOT UNKNOWN. It is well documented innumerable times in countless papers published in peer reviewed medical literature, including JAMA. Here is just one recent paper and if you want to know more about this, “The Art and Science of Low Carbohydrate Living,” by Jeff Volek and Stephen Phinney is a great read. 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 people who change what type of food they eat.
This study had a “lifestyle modification” component modeled on recent “successful clinical trials, particularly the and the .” Note, the Diabetes Prevention Program did show a benefit from intensive lifestyle interventions for people with Metabolic Syndrome and impaired glucose tolerance, but not type 2 diabetes. The interventions were to lose 7% of body weight and to exercising 150 minutes a week. The Look AHEAD Protocol examined whether weight loss reduced the risk of heart attacks and strokes in obese Type 2 diabetics. It did not.
Maybe, just 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 Gastric Bypass study called for “Portion controlled diets using meal replacements, structured menus, and calorie counting were encouraged to help participants stay within calorie limits,” according to the study document. “Both groups [the gastric bypass group and the conventional medical therapy group] met regularly with a trained interventionist to discuss strategies for facilitating weight management and increasing physical activity, including self-monitoring, stimulus control, problem solving, social support, cognitive behavior modification, recipe modification, eating away from home, and relapse prevention.”
“Counseling sessions comprised 24 weekly meetings over the first 6 months, biweekly meetings between months 7 and 9, and monthly meetings between months 10 and 12. The lifestyle intervention protocol was similar for participants in both treatment groups. Patients in to the gastric bypass group, however, delayed initiation of the lifestyle intervention until they could tolerate solid foods (typically 3 to 4 months after surgery), did not have calorie ceilings during the period of rapid weight loss, and received additional instruction regarding food volume and adequate protein intake.” (Very important post-surgical issues)
Maybe I am being too hard on these gastric bypass surgeons. Study participants were 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 glycemia (high blood glucose) and cardiovascular disease risk factors (statins). Perhaps I should ignore the fact that the PI (Principal Investigator), who led the study concept and design, drafting of the manuscript, study supervision, and funding, was also receiving funding from Covidien, a leading manufacturer of medical 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, on the last page, is now called, unabashedly and aptly, “The Diabetes Surgery Study.”I can ignore these funding facts, just as they ignore the simplicity of carbohydrate intolerance. Your meter will tell you if you are eating too many carbs. To achieve control, eat fewer carbs. Your triglyceride levels will also tell you if you are eating too many carbs. Your blood pressure readings will improve too, as you lose weight. Your diet is under your control.