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

This study is currently recruiting participants.
Verified May 2012 by Postgraduate Institute of Medical Education and Research
Sponsor:
Information provided by (Responsible Party):
Anil Bhansali, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01429506
First received: September 4, 2011
Last updated: May 12, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention
Diabetes Mellitus
Obesity
 Procedure: Sleeve gastrectomy
Drug: Intensive medical management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    weight loss at 6 months after the start of intervention


Secondary Outcome Measures:
  • glycemic control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HbA1c and glucose profile


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Intensive medical management will include

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429506

Contacts
Contact: Anil Bhansali, MD, DM 0091-172-2756581 anilbhansali_endocrine@rediffmail.com
Contact: Gaurav Palikhe, MD 0091-9914200256 gauravpalikhe@hotmail.com

Locations
India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Bhansali         anilbhansali_endocrine@rediffmail.com    
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Anil Bhansali, DM, MD PGIMER
  More Information

No publications provided

Responsible Party: Anil Bhansali, Professor, Department of endocrinology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01429506     History of Changes
Other Study ID Numbers: 922861
Study First Received: September 4, 2011
Last Updated: May 12, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
Sleeve gastrectomy
Intensive medical management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013