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Completed

NCT Number: NCT01429506

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

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

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Key information

Conditions

Diabetes Mellitus Body Weight Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PGIMER

Chandigarh, 160012, India

About this study

Intensive medical management will include

  • VLCD
  • Physical activity
  • Exenatide
  • Metformin
  • Insulin detemir

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 2 Diabetics with

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

Exclusion criteria

  • 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

Treatment and study plan

Sleeve gastrectomy

Procedure

Sleeve gastrectomy

Other names: Bariatric surgery, Laparoscopic sleeve gastrectomy

Intensive medical management

Drug

Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet

Primary outcomes

  1. weight loss

    Time frame: 6 months

    weight loss at 6 months after the start of intervention

Secondary outcomes

  1. glycemic control

    Time frame: 6 months

    HbA1c and glucose profile

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2011
Registry last updated
Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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