Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes (IISG)
Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes|
- Percentage of Participants Having Remission of Type 2 Diabetes [ Time Frame: One year ] [ Designated as safety issue: No ]The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped
- Percentage of Participants Not Requiring Insulin [ Time Frame: 1 year ] [ Designated as safety issue: No ]After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months
- Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents [ Time Frame: one year ] [ Designated as safety issue: No ]Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year
- Percentage of Participants Achieving Remission in Hypertension [ Time Frame: 1 year ] [ Designated as safety issue: No ]Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication
|Study Start Date:||January 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy
Procedure: Ileal Interposition with Sleeve Gastrectomy
Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.
Other Name: Laparoscopic Ileal Interposition surgery
Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body upto angle of His with a sizing bougie ranging from size 32--58 Fr.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834626
|Hyderabad, AP, India, 500063|
|Principal Investigator:||Dr Surendra Ugale, MS||Kirloskar Hospital, Hyderabad|