Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive... | NCT01429506

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

NCT01429506

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Last Update Posted

Oct 26, 2015Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus
Obesity

Interventions

Sleeve gastrectomy
Intensive medical management

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Sep 4, 2011

First Submission Date that Met QC Criteria

Sep 6, 2011

First Posted Date

Sep 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2015

Last Update Posted Date

Oct 26, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anil Bhansali, Professor, Department of endocrinology, Post Graduate Institute of Medical Education and Research, ChandigarhPrincipal Investigator

Lead Sponsor

Post Graduate Institute of Medical Education and Research, ChandigarhOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

VLCD
Physical activity
Exenatide
Metformin
Insulin detemir

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sleeve gastrectomy	Procedure	Sleeve gastrectomy	Sleeve gastrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight loss	weight loss at 6 months after the start of intervention	6 months

Secondary Outcomes

Measure	Description	Time Frame
glycemic control	HbA1c and glucose profile	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anil Bhansali, DM, MD	Post Graduate Institute of Medical Education and Research, Chandigarh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PGIMER		Chandigarh	Chandigarh	160012	India

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D009765	Obesity

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided