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

NCT ID: NCT01429506

Last Updated: 2015-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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Intensive medical management will include

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

Conditions

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Diabetes Mellitus Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleeve gastrectomy

Will undergo laparoscopic sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type PROCEDURE

Sleeve gastrectomy

Intensive medical management

Will receive VLCD, exenatide, metformin, insulin detemir

Group Type ACTIVE_COMPARATOR

Intensive medical management

Intervention Type DRUG

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

Interventions

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Sleeve gastrectomy

Sleeve gastrectomy

Intervention Type PROCEDURE

Intensive medical management

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

Intervention Type DRUG

Other Intervention Names

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Bariatric surgery Laparoscopic sleeve gastrectomy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Anil Bhansali

Professor, Department of endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anil Bhansali, DM, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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PGIMER

Chandigarh, Chandigarh, India

Site Status

Countries

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India

Other Identifiers

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922861

Identifier Type: -

Identifier Source: org_study_id

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