Diabetes Mellitus, Obesity
Conditions
Keywords
Sleeve gastrectomy, Intensive medical management
Brief summary
In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.
Detailed description
Intensive medical management will include 1. VLCD 2. Physical activity 3. Exenatide 4. Metformin 5. Insulin detemir
Interventions
PROCEDURESleeve gastrectomy
Sleeve gastrectomy
Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight loss | 6 months | weight loss at 6 months after the start of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| glycemic control | 6 months | HbA1c and glucose profile |
Countries
India
Outcome results
None listed