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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kirloskar Hospital
ClinicalTrials.gov Identifier:
NCT00834626
First received: February 1, 2009
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
 Procedure: Ileal Interposition with Sleeve Gastrectomy

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kirloskar Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Enrollment: 30
Study Start Date: January 2008
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Laparoscopic Ileal Interposition surgery

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.

  Eligibility
Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834626

Locations
India
Kirloskar Hospital
Hyderabad, AP, India, 500063
Sponsors and Collaborators
Kirloskar Hospital
Investigators
Principal Investigator: Dr Surendra Ugale, MS Kirloskar Hospital, Hyderabad
  More Information

Publications:

Responsible Party: Kirloskar Hospital
ClinicalTrials.gov Identifier: NCT00834626     History of Changes
Other Study ID Numbers: KH-001
Study First Received: February 1, 2009
Results First Received: February 3, 2011
Last Updated: August 30, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Kirloskar Hospital:
Ileal Interposition
Sleeve Gastrectomy
Type-2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on February 25, 2015