| CTRI Number |
CTRI/2008/091/000206 [Registered on: 17/11/2008] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate effect of surgery for control of Type2 diabetes in overweight individuals |
|
Scientific Title of Study
|
A clinical trial of surgical treatment of Type2 Diabetes in non morbidly obese patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramen Goel |
| Designation |
|
| Affiliation |
|
| Address |
125,MRC Building,
Bombay Hospital,12 New Marine lines
Mumbai
MAHARASHTRA
400020
India |
| Phone |
+91229820170763 |
| Fax |
|
| Email |
obesityclinic@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramen Goel |
| Designation |
|
| Affiliation |
Honarary Associate Professor of Surgery, Grant Medical College |
| Address |
125,MRC building,
Bombay Hospital,12 New Marine lines
Mumbai
MAHARASHTRA
400020
India |
| Phone |
0229820170763 |
| Fax |
|
| Email |
obesityclinic@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu Goel |
| Designation |
|
| Affiliation |
|
| Address |
Levioza Clinic, Pushpanjali Building
S V Road, Santacruz(W),
Mumbai
MAHARASHTRA
India |
| Phone |
022 9323599309 |
| Fax |
|
| Email |
obesity-care@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramen Goel |
Bombay Hospital |
125, MRC Building, Bombay Hospital,New Marine Lines-400020
Mumbai
MAHARASHTRA |
022 22067676 Ext 388
obesityclinic@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bombay Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sleeve Gastrectomy with Ileal Transposition Surgery |
Post op follow up of 1 year to assess glycemic control |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1.Diagnosed Type 2 Diabetes for 1-5 years
2. Poorly controlled blood sugar despite standard of care as demonstrated by HbA1C 8-11 & 3 office visits
3. BMI between 23.0 and 35
4. Stable weight as determined by no more than a 3% change in body weight in the last 3 months.
5. Age between 25 and 65(both men & women will be included)
6. Able to provide Informed Consent.
7. Able to comply with follow-up procedures. |
|
| ExclusionCriteria |
| Details |
1. Previous history of major abdominal surgery which may lead to a hostile abdomen.
2. Pregnancy
3. Patients who have an incurable malignant or debilitating disease.
4. Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs, kidney or heart
5. Diagnosed severe eating disorder
6. Untreated endocrine disorder
7. Active peptic ulcer
8. Untreated H. pylori
9. Cognitive Impairment
10. Diabetic autonomic neuropathy
11. Symptomatic gastroparesis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction or Stoppage of anti-diabetic medication |
3 months & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glycemic Control with HbA1C < 6.5 |
6 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/10/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a single arm trial to evaluate efficacy of sleeve gastrectomy with ileal transposition surgery on control of type 2 diabetes mellitus. The study will be conducted at Bombay Hospital, Mumbai in 100 patients. Primary outcome will be to assess reduction/stoppage of anti-diabetic medication in 3 months - 6 months. Secondary outcome will measure glycosylated hemoglobin A1C levels <6.5 at 6 months & 12 months after surgery. |