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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01429506
First Posted: September 7, 2011
Last Update Posted: October 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anil Bhansali, Postgraduate Institute of Medical Education and Research
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • weight loss [ Time Frame: 6 months ]
    weight loss at 6 months after the start of intervention


Secondary Outcome Measures:
  • glycemic control [ Time Frame: 6 months ]
    HbA1c and glucose profile


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: August 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429506


Locations
India
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Anil Bhansali, DM, MD Postgraduate Institute of Medical Education and Research
  More Information

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
First Submitted: September 4, 2011
First Posted: September 7, 2011
Last Update Posted: October 26, 2015
Last Verified: October 2015

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

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