NCT01429506

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 26, 2015

Status Verified

October 1, 2015

Enrollment Period

1.6 years

First QC Date

September 4, 2011

Last Update Submit

October 23, 2015

Conditions

Diabetes MellitusObesity

Keywords

Sleeve gastrectomyIntensive medical management

Outcome Measures

Primary Outcomes (1)

  • weight loss

    weight loss at 6 months after the start of intervention

    6 months

Secondary Outcomes (1)

  • glycemic control

    6 months

Study Arms (2)

Sleeve gastrectomy

ACTIVE COMPARATOR

Will undergo laparoscopic sleeve gastrectomy

Procedure: Sleeve gastrectomy

Intensive medical management

ACTIVE COMPARATOR

Will receive VLCD, exenatide, metformin, insulin detemir

Drug: Intensive medical management

Interventions

Sleeve gastrectomyPROCEDURE

Sleeve gastrectomy

Also known as: Bariatric surgery, Laparoscopic sleeve gastrectomy
Sleeve gastrectomy
Intensive medical managementDRUG

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

Intensive medical management

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Diabetes MellitusObesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Anil Bhansali, DM, MD

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of endocrinology

Study Record Dates

First Submitted

September 4, 2011

First Posted

September 7, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 26, 2015

Record last verified: 2015-10

Locations

IN(1)