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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Obesity
• Interventions: Procedure: Sleeve gastrectomy; Drug: Intensive medical management

• Registration Number: NCT01429506
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-09-04
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve gastrectomy	Sleeve gastrectomy	Will undergo laparoscopic sleeve gastrectomy
Intensive medical management	Intensive medical management	Will receive VLCD, exenatide, metformin, insulin detemir

Primary Outcome Measures

Name	Time	Method
weight loss	6 months	weight loss at 6 months after the start of intervention

Secondary Outcome Measures

Name	Time	Method
glycemic control	6 months	HbA1c and glucose profile

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, India