Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes (IISG)

August 30, 2012 updated by: Kirloskar Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • AP
      • Hyderabad, AP, India, 500063
        • Kirloskar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgery group
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 Names:
  • Laparoscopic Ileal Interposition surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Having Remission of Type 2 Diabetes
Time Frame: 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
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Not Requiring Insulin
Time Frame: 1 year
After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months
1 year
Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents
Time Frame: 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
one year
Percentage of Participants Achieving Remission in Hypertension
Time Frame: 1 year
Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirloskar Hospital

Investigators

  • Principal Investigator: Dr Surendra Ugale, MS, Kirloskar Hospital, Hyderabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 1, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (Estimate)

February 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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