This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Type 2 diabetes mellitus (T2DM) is a major contributor to cardiovascular disease (CVD). Individuals with T2DM are at particularly high risk for CVD morbidity and mortality. Medical and behavioral management of glycemia and CVD risk factors has been shown to ameliorate complications of T2DM and CVD events. However, lack of access to care, suboptimal compliance, adverse effects and expense of some treatments limit the success of medical strategies for T2DM. The Roux-en-Y gastric bypass (RYGB) has resulted in dramatic remission rates (82%) of T2DM in severely obese patients and superior clinical outcomes in retrospective comparisons with patients treated with conventional medical management. Currently, utilization of the RYGB is commonly limited to patients with body mass index (BMI) greater than 35 kg/m2. The efficacy of the RYGB for T2DM patients with BMI less than 35 kg/m2 has not been prospectively studied. We propose to perform a randomized Risk Factor Clinical Trial to assess the safety and efficacy on reduction of hyperglycemia and CVD risk factors of the RYGB compared to IMM alone. The trial will recruit and randomize 120 patients (60 each to the RYGB and IMM arms) and follow them for 12 months to assess safety, efficacy, and compliance with each arm.
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