Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
NCT ID: NCT01429506
Last Updated: 2015-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2011-01-31
2012-08-31
Brief Summary
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Detailed Description
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1. VLCD
2. Physical activity
3. Exenatide
4. Metformin
5. Insulin detemir
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sleeve gastrectomy
Will undergo laparoscopic sleeve gastrectomy
Sleeve gastrectomy
Sleeve gastrectomy
Intensive medical management
Will receive VLCD, exenatide, metformin, insulin detemir
Intensive medical management
Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet
Interventions
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Sleeve gastrectomy
Sleeve gastrectomy
Intensive medical management
Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. BMI ≥ 27.5 kg/m2
2. HbA1c 7-10%
3. Age 20-70 years
Exclusion Criteria
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
20 Years
70 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Anil Bhansali
Professor, Department of endocrinology
Principal Investigators
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Anil Bhansali, DM, MD
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Institute of Medical Education and Research, Chandigarh
Locations
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PGIMER
Chandigarh, Chandigarh, India
Countries
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Other Identifiers
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922861
Identifier Type: -
Identifier Source: org_study_id
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