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Sponsored by: |
Kirloskar Hospitals |
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Information provided by: | Kirloskar Hospitals |
ClinicalTrials.gov Identifier: | NCT00834626 |
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.
Condition | Intervention |
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Diabetes |
Procedure: Sleeve gastrectomy with Ileal switch surgery |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Interventional Study of Effects of Sleeve Gastrectomy With Ileal Switch for Control of Type 2 Diabetes |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Surgery group
Observational study of the effects of a novel bariatric surgery
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Procedure: Sleeve gastrectomy with Ileal switch surgery
Transposition of a segment of Ileum proximally coupled with sleeve gastrectomy.
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An ileal segment of 100 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 was done starting from antrum upto angle of His.
Ages Eligible for Study: | 30 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Kirloskar Hospitals ( Dr Suren Ugale ) |
Study ID Numbers: | KH-001 |
Study First Received: | February 1, 2009 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00834626 History of Changes |
Health Authority: | India: Institutional Review Board |
Ileal interposition Sleeve Gastrectomy Bariatric surgery |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |