Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes

October 23, 2015 updated by: Anil Bhansali, Postgraduate Institute of Medical Education and Research

Effect of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes

In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intensive medical management will include

  1. VLCD
  2. Physical activity
  3. Exenatide
  4. Metformin
  5. Insulin detemir

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
      • Chandigarh, India, 160012
        • PGIMER

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Type 2 Diabetics with

  1. BMI ≥ 27.5 kg/m2
  2. HbA1c 7-10%
  3. Age 20-70 years

Exclusion Criteria:

  1. Prior gastric surgery
  2. Pregnancy and lactation
  3. renal disease (GFR < 60 ml/min)
  4. Pancreatitis
  5. Symptomatic gallstone disease
  6. Active malignancy
  7. Secondary causes of obesity ( Cushing's syndrome, uncontrolled Hypothyroidism)
  8. Severe psychiatric illness
  9. Allergic reaction to exenatide

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sleeve gastrectomy
Will undergo laparoscopic sleeve gastrectomy
Procedure: Sleeve gastrectomy
Sleeve gastrectomy
Other Names:
  • Bariatric surgery
  • Laparoscopic sleeve gastrectomy
Active Comparator: Intensive medical management
Will receive VLCD, exenatide, metformin, insulin detemir
Drug: Intensive medical management
Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: 6 months
weight loss at 6 months after the start of intervention
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycemic control
Time Frame: 6 months
HbA1c and glucose profile
6 months

Collaborators and Investigators

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

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Anil Bhansali, DM, MD, Postgraduate Institute of Medical Education and Research

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, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 4, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 922861

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.

Clinical Trials on Obesity

Clinical Trials on Sleeve gastrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe