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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429506
• Other study ID #: 922861
• Status: Completed
• Phase: N/A
• First received: September 4, 2011
• Last updated: October 23, 2015
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Intensive medical management will include

1. VLCD

2. Physical activity

3. Exenatide

4. Metformin

5. Insulin detemir

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity

Intervention

Procedure:
• Sleeve gastrectomy
Sleeve gastrectomy

Drug:
• Intensive medical management
Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	weight loss at 6 months after the start of intervention	6 months	No
Secondary	glycemic control	HbA1c and glucose profile	6 months	No