Interventional Study of Effects of Sleeve Gastrectomy With Ileal interposition for Control of Type 2 Diabetes

Protocol SummaryTitle :Interventional Study of Effects of Sleeve Gastrectomy With Ileal interposition for Control of Type 2 DiabetesIntroduction: Metabolic surgery offers the best solution in management of obesity and related metabolic ailments. We report the results of a novel surgical procedure on glycemic control and metabolic syndrome in poorly controlled type 2 diabetes.Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated GLP-1 secretion and coupled with a restrictive procedure of sleeve gastrectomy helps in achieving good glycemic control in Type 2 Diabetes patients.Objectives: To evaluate the effects of Sleeve Gastrectomy with Ileal Switch on the metabolic parameters in patients with Type 2 Diabetes.Primary end-point: 1.Remission of Type 2 Diabetes - HbA1c < 6Secondary End points: 2.Change in requirement of hypoglycemic agents3.Change in body weight4.Change in individual components of the metabolic syndromeInclusion Criteria:?age- 25-65 years.?Body Mass Index between 25-35 kf/m2.?currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.?Documented HbA1c>7.5% for at least 3 months.?Stable weight for 3 months (+/-)?Evidence of stable medical treatment for diabetes over the past 12 months.?Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -Exclusion Criteria:?Type I diabetes/juvenile onset?C-Peptid levels below 1.0 ng/ml?Previous major upper abdominal surgery?Pregnant or plans to become pregnant with in the next 12 months?Current Malignancy?Severe pulmonary, cardiac, or renal disease?Eating disorders such as bulimia or binge-eating?Severe mental health disorders such as schizophrenia and bipolar disorder?Obesity due to other metabolic disorders?taking appetite suppressants?currently abusing illicit drugs, alcohol or using tobacco products?Unable to provide informed consent?Unwillingness or unable to comply with study procedures?any condition that deems them unsuitable for the study in the opinion of the investigatorsNumber of Sites: One - Fortis hospital bannerghatta road, Bangalore.Study Duration : Dec 2010 to completion of one year follow up of 20 subjects.Subject Participation Duration: One year following the completion of surgery.Description of Agent or Intervention: An ileal segment of 130 cms was taken out about 50 cm proximal to ileo cecal valve and interposed proximally into proximal jejunum about 30 cm distal to Ligament of Treitz. Sleeve gastrectomy ( parial and total) was done starting from antrum upto angle of His.Estimated Time to Complete Enrollment: 6 months