| CTRI Number |
CTRI/2013/10/004115 [Registered on: 30/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
21/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Laparoscopic Ileal Interposition with Sleeve Gastrectomy for control of Type-2 Diabetes
|
|
Scientific Title of Study
|
Laparoscopic Ileal Interposition with Sleeve Gastrectomy for control of Type-2 Diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00834626 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surendra Ugale |
| Designation |
Director Advanced Laparoscopy and Metabolic Surgery |
| Affiliation |
Kirloskar Hospital |
| Address |
Kirloskar Hospital
Bashir Bagh
Hyderabad
ANDHRA PRADESH
500063
India |
| Phone |
9573200951 |
| Fax |
04023296245 |
| Email |
drugale@kirloskarhospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Ugale |
| Designation |
Director Advanced Laparoscopy and Metabolic Surgery |
| Affiliation |
Kirloskar Hospital |
| Address |
Kirloskar Hospital
Bashir Bagh
Hyderabad
ANDHRA PRADESH
500063
India |
| Phone |
9573200951 |
| Fax |
04023296245 |
| Email |
drugale@kirloskarhospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Gupta |
| Designation |
Associate Surgeon Advanced Laparoscopy and Metabolic Surgery |
| Affiliation |
Kirloskar Hospital |
| Address |
Kirloskar Hospital
Bashir Bagh
Hyderabad
ANDHRA PRADESH
500063
India |
| Phone |
9849004365 |
| Fax |
04023296245 |
| Email |
whatneeraj@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kirloskar Hospital |
| Address |
Bashir Bagh,
Hyderabad, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Neeraj Gupta |
Kirloskar Hospital |
Bashir Bagh,-500063
Hyderabad
ANDHRA PRADESH |
9849004365
04023296245
whatneeraj@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kirloskar Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ileal Interposition with Sleeve Gastrectomy |
1 year |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed Type 2 Diabetes for 2-30 years 2. C-Peptide levels of more than 1ng/ml 3. Patients with any BMI 4. Age between 20 and 70 (both men & women included) 5. Able to provide Informed Consent. 6. Able to comply with follow-up tests and check-up |
|
| ExclusionCriteria |
| Details |
1.Pregnancy 2. Patients who have an incurable malignant or debilitating disease. 3. Serious uncorrectable impairment of coagulation (INR>1.4, PTT > + 3 secs), lungs, kidney or heart 4. Diagnosed severe eating disorder 5. Untreated endocrine disorder 6. Active peptic ulcer 7. Untreated H. pylori 9. Cognitive Impairment |
|
|
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, 6, 9 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glycemic Control with HbA1C 6.5 |
6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1.Diabetes Technol Ther. 2009 Dec;11(12):785-9. Ileal interposition with sleeve gastrectomy for control of type 2 diabetes. Kumar KV, Ugale S, Gupta N, Naik V, Kumar
2.Remission of Type 2 Diabetes Mellitus by Ileal Interposition with Sleeve gastrectomy
------Kumar Kota S, Ugale S, Gupta N, Naik V, Krishna Kota S, Hari Kumar Kvs, Modi KD. .
J Endcrinol Metab. 2011;9(3):374-81. DOI: 10.5812/Kowsar.1726913X.2782
International Journal of Endocrinology & Metabolism
|
|
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 ileal interposition with sleeve gastrectomy surgery on control of type 2 diabetes mellitus. The study will be conducted at Kirloskar Hospital, Hyderabad in 30 patients. Primary outcome will be to assess reduction/stoppage of anti-diabetic medication in 3 months - 12 months. Secondary outcome will measure glycosylated hemoglobin A1C levels at 6 months & 12 months after surgery |