Status:

COMPLETED

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

Lead Sponsor:

Post Graduate Institute of Medical Education and Research, Chandigarh

Conditions:

Diabetes Mellitus

Obesity

Eligibility:

All Genders

20-70 years

Phase:

NA

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

Eligibility Criteria

Inclusion

  • Type 2 Diabetics with
  • BMI ≥ 27.5 kg/m2
  • HbA1c 7-10%
  • Age 20-70 years

Exclusion

  • Prior gastric surgery
  • Pregnancy and lactation
  • renal disease (GFR \< 60 ml/min)
  • Pancreatitis
  • Symptomatic gallstone disease
  • Active malignancy
  • Secondary causes of obesity ( Cushing's syndrome, uncontrolled Hypothyroidism)
  • Severe psychiatric illness
  • Allergic reaction to exenatide

Key Trial Info

Start Date :

January 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2012

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01429506

Start Date

January 1 2011

End Date

August 1 2012

Last Update

October 26 2015

Active Locations (1)

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PGIMER

Chandigarh, Chandigarh, India, 160012