Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Procedure: Ileal Interposition with Sleeve Gastrectomy

• Registration Number: NCT00834626
• Lead Sponsor: Kirloskar Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-02-01
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Primary Completion: 2010-05
• Results First Submitted: 2011-02-03
• Study Completion: 2011-05
• Results First Submitted QC: 2012-07-27
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-30
• Results First Posted: 2012-08-31
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Type 2 Diabetes (as defined by American Diabetes Association criteria)of more than 1 year duration
• Body Mass Index 21 - 55 kg/m^2
• Poor glycemic control (HbA1c > 8%) despite maximal use of Oral Hypoglycemic Agents and Insulin; or good control(lower HbA1c) but requiring progressively higher drug doses.
• Gives Informed Consent for the surgery
• Postmeal C peptide > 1.0 ng/mL
• Age 25 - 75 years
• Stable weight for more than 3 months

Exclusion Criteria

• Type 1 Diabetes
• Postmeal C peptide < 1 ng/mL
• Pregnancy
• Significant nephropathy requiring dialysis
• Coexisting systemic disease
• Previous gastric or intestinal resection surgery
• Obesity due to organic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery group	Ileal Interposition with Sleeve Gastrectomy	Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Having Remission of Type 2 Diabetes	One year	The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Not Requiring Insulin	1 year	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	one year	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	1 year	Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication

Trial Locations

Locations (1)

Kirloskar Hospital; 🇮🇳 Hyderabad, AP, India