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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Diabetes Mellitus; Obesity

Treatments: Drug: Intensive medical management; Procedure: Sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01429506

922861

Details and patient eligibility

About

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

Full description

Intensive medical management will include

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

Enrollment: 30 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Sleeve gastrectomy

Active Comparator group

Description:

Will undergo laparoscopic sleeve gastrectomy

Treatment:

Procedure: Sleeve gastrectomy

Intensive medical management

Active Comparator group

Description:

Will receive VLCD, exenatide, metformin, insulin detemir

Treatment:

Drug: Intensive medical management