We now have evidence to support what we believe: bariatric surgery is better than medical care for the treatment of diabetes. In two landmark articles published this week in The New England Journal of Medicine, Dr. Philip Schauer and colleagues from the Cleveland Clinic and Dr. Geltrude Mingrone and colleagues from the Catholic University of Rome and the Weill Medical College of Cornell University demonstrate improved diabetes remission in surgery patients compared to patients randomized to receive best medical care.
The observed positive changes relative to diabetes remission may even occur before substantial weight loss, which generally takes weeks to months.
The Schauer study is a randomized, controlled, single-center study, called the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial. The co-investigators randomized 150 type 2 diabetic patients with body mass index (BMI) between 27 and 43 and glycated hemoglobin level of less than 7.0% to receive either aggressive medical therapy or surgical management with sleeve gastrectomy or Roux-en-Y gastric bypass (RYGB).
Subjects were followed every three months for a year with the therapeutic goal of a glycated hemoglobin level of 6.0% or less. Ninety-three percent of patients completed the 12-month study and were analyzed for outcomes. The therapeutic goal was met in 5 of 41 (12%) of medical patients, 21 of 50 (42%) RYGB patients, and 18 of 49 (37%) sleeve gastrectomy patients.
All 21 gastric bypass patients who achieved control did so off medication and only 5 of 18 responding (28%) sleeve patients required medication support. Not surprising, the surgical patients also lost more weight than the medical group. In addition, other cardiovascular risk factors (hypertension and hyperlipidemia) improved.
Type 2 diabetes — closely associated with obesity — is one of the fastest growing epidemics in human history.
The Mingrone study randomized 60 patients with type 2 diabetes and glycated hemoglobin of less than 7.0 followed for two years to medical therapy or surgery with RYGB or biliopancreatic-diversion (BPD). The end-point of a glycated hemoglobin level of less than 6.5% in the absence of pharmacologic therapy was achieved in no medical patients, compared to 15 of 20 (75 %) RYGB and 19 of 20 (95%) BPD patients. The most common postoperative complication was iron deficiency anemia in 10.5% of patients.
Dr. Mingrone and colleagues conclude that surgery is preferred to medical management of diabetes: "In severely obese patients with type 2 diabetes, bariatric surgery resulted in better glucose control than did medical therapy. Preoperative BMI and weight loss did not predict the improvement in hyperglycemia after these procedures."
Dr. Robin Blackstone, president of the American Society of Metabolic and Bariatric Surgery, is hopeful that the evidence of both studies will encourage insurers to extend surgical coverage to diabetic patients sooner than current standards, or even with lower BMI:
"These ground-breaking studies will have a major impact on the future of diabetes treatment as clinicians, patients, government officials, and insurers absorb the data and its implications. But while bariatric surgery proved more effective than medical therapy for type 2 diabetes, the real winner is patients, who may now gain greater access to a safe and proven treatment that has been denied too long to too many." (See Dr. Blackstone's full statement.)
The Bariatric and Metabolic Weight Loss Center here at Stony Brook works with our patients to treat diabetes. For more information about our program or to register for a educational seminar, please visit us on the web.
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