| CTRI Number |
CTRI/2010/091/003059 [Registered on: 27/12/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Single Arm Study |
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Public Title of Study
|
A clinical trial of Sleeve Gastrectomy With Ileal interposition for Control of Type 2 Diabetes |
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Scientific Title of Study
|
Interventional Study of Effects of Sleeve Gastrectomy With Ileal interposition for Control of Type 2 Diabetes |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shabeer Ahmed |
| Designation |
|
| Affiliation |
|
| Address |
Consultant Fortis hospitals 154/9 Bannerghatta road Opp IIMB
Bangalore
KARNATAKA
560076
India |
| Phone |
08066214016 |
| Fax |
|
| Email |
surgeonshabeer@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabeer Ahmed |
| Designation |
|
| Affiliation |
|
| Address |
Consultant Fortis hospitals 154/9 Bannerghatta road Opp IIMB
Bangalore
KARNATAKA
560076
India |
| Phone |
08066214016 |
| Fax |
|
| Email |
surgeonshabeer@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabeer Ahmed |
| Designation |
|
| Affiliation |
|
| Address |
Consultant Fortis hospitals 154/9 Bannerghatta road Opp IIMB
Bangalore
KARNATAKA
560076
India |
| Phone |
08066214016 |
| Fax |
|
| Email |
surgeonshabeer@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Fortis hospitals 154/9 Bannerghatta road Opp IIMB Bangalore |
|
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Primary Sponsor
|
| Name |
Dr Shabeer Ahmed |
| Address |
|
| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shabeer Ahmed |
Fortis hospitals |
154/9 Bannerghatta road Opp IIMB ,-560076
Bangalore
KARNATAKA |
08066214016
surgeonshabeer@hotmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Fortis hospital ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes mellitus, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effects of Sleeve Gastrectomy With Ileal interposition for Control of Type 2 Diabetes |
one year follow up |
| Comparator Agent |
Nil |
Nil |
|
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Inclusion Criteria
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| Age From |
|
| Age To |
|
| Gender |
|
| Details |
? age- 25-65 years.
? Body Mass Index between 25-35 kf/m2.
? currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
? Documented HbA1c>7.5% for at least 3 months.
? Stable weight for 3 months (+/-)
? Evidence of stable medical treatment for diabetes over the past 12 months.
? Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -
|
|
| ExclusionCriteria |
| Details |
? Type I diabetes/juvenile onset
? C-Peptid levels below 1.0 ng/ml
? Previous major upper abdominal surgery
? Pregnant or plans to become pregnant with in the next 12 months
? Current Malignancy
? Severe pulmonary, cardiac, or renal disease
? Eating disorders such as bulimia or binge-eating
? Severe mental health disorders such as schizophrenia and bipolar disorder
? Obesity due to other metabolic disorders
? taking appetite suppressants
? currently abusing illicit drugs, alcohol or using tobacco products
? Unable to provide informed consent
? Unwillingness or unable to comply with study procedures
? any condition that deems them unsuitable for the study in the opinion of the investigators
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Remission of Type 2 Diabetes - HbA1c < 6 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Change in requirement of hypoglycemic agents
Change in body weight
Change in individual components of the metabolic syndrome |
|
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Target Sample Size
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Total Sample Size="20"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/12/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Protocol Summary
Title :Interventional Study of Effects of Sleeve Gastrectomy With Ileal interposition for Control of Type 2 Diabetes
Introduction:
Metabolic surgery offers the best solution in management of obesity and related metabolic ailments. We report the results of a novel surgical procedure on glycemic control and metabolic syndrome in poorly controlled type 2 diabetes.
Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated GLP-1 secretion and coupled with a restrictive procedure of sleeve gastrectomy helps in achieving good glycemic control in Type 2 Diabetes patients.
Objectives:
To evaluate the effects of Sleeve Gastrectomy with Ileal Switch on the metabolic parameters in patients with Type 2 Diabetes.
Primary end-point:
1. Remission of Type 2 Diabetes - HbA1c < 6
Secondary End points:
2. Change in requirement of hypoglycemic agents
3. Change in body weight
4. Change in individual components of the metabolic syndrome
Inclusion Criteria:
? age- 25-65 years.
? Body Mass Index between 25-35 kf/m2.
? currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
? Documented HbA1c>7.5% for at least 3 months.
? Stable weight for 3 months (+/-)
? Evidence of stable medical treatment for diabetes over the past 12 months.
? Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -
Exclusion Criteria:
? Type I diabetes/juvenile onset
? C-Peptid levels below 1.0 ng/ml
? Previous major upper abdominal surgery
? Pregnant or plans to become pregnant with in the next 12 months
? Current Malignancy
? Severe pulmonary, cardiac, or renal disease
? Eating disorders such as bulimia or binge-eating
? Severe mental health disorders such as schizophrenia and bipolar disorder
? Obesity due to other metabolic disorders
? taking appetite suppressants
? currently abusing illicit drugs, alcohol or using tobacco products
? Unable to provide informed consent
? Unwillingness or unable to comply with study procedures
? any condition that deems them unsuitable for the study in the opinion of the investigators
Number of Sites: One - Fortis hospital bannerghatta road, Bangalore.
Study Duration : Dec 2010 to completion of one year follow up of 20 subjects.
Subject Participation Duration: One year following the completion of surgery.
Description of Agent or Intervention:
An ileal segment of 130 cms was taken out about 50 cm proximal to ileo cecal valve and interposed proximally into proximal jejunum about 30 cm distal to Ligament of Treitz. Sleeve gastrectomy ( parial and total) was done starting from antrum upto angle of His.
Estimated Time to Complete Enrollment: 6 months
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