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Title: Comparing the Effects of Surgery vs Medical Therapy in the Management of Type 2 Diabetes

PI:Francesco Rubino, MD

Institution: Weill Cornell Medical College

IRB#: 1002010906

IRB Expiration Date: 6/26/2012

Study Description: The three purposes of this study are: 1) to investigate whether or not gastrointestinal surgery can control diabetes in overweight-to-moderately obese patients, 2) to compare diabetes control after surgery versus medical treatment of diabetes in overweight-to-moderately obese patients, and 3) to determine if clinical trials comparing medication and surgery can be performed with regard to randomizing groups and recruiting subjects.

Previous research studies have suggested that it may be appropriate to provide surgical treatment for diabetes in patients who do not meet existing obesity-based criteria for bariatric surgery. This study aims to investigate whether gastric bypass surgery is safe and effective in controlling diabetes in moderately obese or overweight individuals, and whether the results of a surgical approach compare favorably with those of optimal medical treatment for the same patient population. The results of this study will also inform researchers about the design of future larger multicenter trials to answer the question of whether surgery may be better than medical therapy in ameliorating not only blood sugar control, but also diabetes-related complications, particularly the risk of cardiovascular disease. Research in diabetes surgery may help clarify the role of surgery in the treatment of diabetes in less obese patients. If this or future studies shows that surgery is a safe and effective option, surgery may become an option for many patients who do not qualify for bariatric surgery with current clinical and health insurance criteria. The study also aims to understand mechanisms of the surgical control of diabetes. For this reason, the study may help advance the understanding of diabetes, and lead to less invasive treatment or better medications. The cost of surgery and pre and post surgical assessments are covered by this study.

Involvement:: Medical therapy or Gastric Bypass surgery

Age: 21-65 years

Eligibility: Diagnosis of Type 2 Diabetes within the past 15 years, hemoglobin A1c: 7-10%, BMI: 26-34 kg/m2

Commitment:Up to 5 years

Contact: Catherine Wedick at 212-746-5725 or cew2007@med.cornell.edu

Sponsor(s): Covidien