Sleeve Gastrectomy With Ileal Switch for Diabetes Control - Full Text View

Sponsored by:	Kirloskar Hospitals
Information provided by:	Kirloskar Hospitals
ClinicalTrials.gov Identifier:	NCT00834626

Purpose

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
Diabetes	Procedure: Sleeve gastrectomy with Ileal switch surgery

MedlinePlus related topics: Diabetes Surgery

U.S. FDA Resources

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

Further study details as provided by Kirloskar Hospitals:

Primary Outcome Measures:

Remission of Type 2 Diabetes [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decrease in requirement of hypoglycemic agents [ Time Frame: one year ] [ Designated as safety issue: No ]

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	Procedure: Sleeve gastrectomy with Ileal switch surgery Transposition of a segment of Ileum proximally coupled with sleeve gastrectomy.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes (as defined by ADA criteria)of more than 2 years duration
BMI > 27 kg/m2
Poor glycemic control (HbA1c > 7%) despite maximal use of OHA and Insulin
Gives Informed Consent for the surgery

Exclusion Criteria:

Type 1 Diabetes
Significant nephropathy (creatinine > 2mg/dL)
Coexisting systemic disease
Previous gastric or intestinal resection surgery

Contacts and Locations

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

Locations

India, AP
Kirloskar Hospitals
Hyderabaad, AP, India, 500063

Sponsors and Collaborators

Kirloskar Hospitals

Investigators

Principal Investigator:

Dr Suren Ugale, MS

Kirloskar Hospitals, Hyderabad

More Information

No publications provided

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

Keywords provided by Kirloskar Hospitals:

Ileal interposition
Sleeve Gastrectomy
Bariatric surgery

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009