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Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes - NCT00432809-44195(Clinical Trial 162144)



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City:  Cleveland
State:  
OH
Zip Code: 44195
Conditions: Diabetes Mellitus, Type 2 - Obesity
Purpose: The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.
Study summary:
Criteria: Inclusion Criteria: - Type 2 diabetes mellitus with HbA1c > 7.0% - Body mass index > 27 and < 43 kg/m2 - Candidate for general anesthesia Exclusion Criteria: - Prior bariatric surgery of any kind - Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension - Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl - Known history of chronic liver disease (except for NAFLD/NASH) - Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease - Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months - Severe pulmonary disease defined as FEV1 < 50% of predicted value - Pregnancy
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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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