| CTRI Number |
CTRI/2019/05/019396 [Registered on: 28/05/2019] Trial Registered Prospectively |
| Last Modified On: |
28/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Glucose Intolerance Among New patients with Tuberculosis |
|
Scientific Title of Study
|
Determining the best screening strategies for detecting glucose intolerance and diabetes mellitus in patients with mycobacterium tuberculosis |
| Trial Acronym |
GIANT Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Jubbin Jagan Jacob |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Clinical Trial Unit
Department of Endocrinology
Christian Medical College and Hospital
Ludhiana
DEPARTMENT OF ENDOCRINOLOGY
CHRISTIAN MEDICAL COLLEGE
Brown Road,
Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
09915281219 |
| Fax |
|
| Email |
jubbin.jacob@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jubbin Jagan Jacob |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Clinical Trial Unit
Department of Endocrinology
Christian Medical College and Hospital
Ludhiana
DEPARTMENT OF ENDOCRINOLOGY
CHRISTIAN MEDICAL COLLEGE
Brown Road,
Ludhiana
PUNJAB
141008
India |
| Phone |
09915281219 |
| Fax |
|
| Email |
jubbin.jacob@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Jubbin Jagan Jacob |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Clinical Trial Unit
Department of Endocrinology
Christian Medical College and Hospital
Ludhiana
DEPARTMENT OF ENDOCRINOLOGY
CHRISTIAN MEDICAL COLLEGE
Brown Road,
Ludhiana
PUNJAB
141008
India |
| Phone |
09915281219 |
| Fax |
|
| Email |
jubbin.jacob@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Society for Study of Diabetes in India (RSSDI)
RSSDI Secretariat
Dr. Makkar’s Diabetes & Obesity Centre
A -5 B/122, Paschim Vihar,New Delhi-110063 (India)
Tel: 011 - 27061022
Email: rssdihq@gmail.com
Website:www.rssdi.in
|
|
|
Primary Sponsor
|
| Name |
RSSDI |
| Address |
RSSDI Secretariat
Dr. Makkar’s Diabetes and Obesity Centre
A5, B122, Paschim Vihar,New Delhi |
| Type of Sponsor |
Other [Medical Society ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Jubbin Jagan Jacob |
Christian Medical College and Hospital |
Clinical Trial Unit,
Department of Endocrinology
CMCH, Ludhiana
Ludhiana
PUNJAB |
9915281219
jubbin.jacob@gmail.com |
| Dr Sudeep K |
Father Muller Medical college Hospital |
Endocrinology Unit,
Father Muller Medical College Hospital,
Mangalore. 575002
Dakshina Kannada
KARNATAKA |
9483928329
drsudeepmd@rediffmail.com |
| Prof Sarita Bajaj |
MLN Medical College |
Department of Medicine
MLN Medical College
Pragyaraj
Allahabad
UTTAR PRADESH |
9415239392
drsarita.bajaj@gmail.com |
| Prof Rakesh Sahay |
Osmania Medical College & Osmania General Hospital |
Department of Endocrinology
Osmania Medical College & Osmania General Hospital
Hyderabad
Hyderabad
TELANGANA |
9849597507
sahayrk@gmail.com |
| Prof Dhruva Choudhary |
Post Graduate Institute of Medical Sciences |
UHS, Rohtak 124001, Haryana
Rohtak
HARYANA |
9991101616
dhruvachaudhry@yahoo.co.in |
| Dr Mangesh Tiwaskar |
Shilpa Medical Research Centre |
Shilpa Medical Research Centre,
Rainbow Apts., Avdhoot Nagar, Dahisar (E) Mumbai 400068, Maharashtra, India.
Mumbai
MAHARASHTRA |
9849597507
tiwaskar@gmail.com |
| Prof Jayant Panda |
SLN Medical College |
Dept of Medicine,
SLN Medical College, Cuttack
Odisha
Cuttack
ORISSA |
9437028282
drjayantpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee, Osmania Medical College |
Approved |
| Ethics Committee, SLN Medical College |
Submittted/Under Review |
| Father Muller Medical College, Institiutional Ethics Committee |
Approved |
| MLN Medical College, Allahabad |
Not Applicable |
| PGIMS Haryana |
Submittted/Under Review |
| Shilipa Medical Research Centre |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A15-A19||Tuberculosis, (2) ICD-10 Condition: A180||Tuberculosis of bones and joints, (3) ICD-10 Condition: A181||Tuberculosis of genitourinary system, (4) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive adults with tuberculosis infection determined bacteriologically, histologically or clinically were anti-tubercular drugs are planned to be prescribed would be recruited after informed consent |
|
| ExclusionCriteria |
| Details |
Patients with serious life threatening tuberculosis infection, previous diagnosis of diabetes mellitus, pregnant women, those on steroid therapy or planned for steroid therapy and those unwilling for study related diagnostic procedures. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the most robust strategy and the best time for diagnosis of diabetes mellitus in patients with mycobacterium tuberculosis |
1. At Diagnosis
2. Three month after Diagnosis
3. End of treatment patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine prevalence of glucose intolerance (diabetes mellitus, prediabetes and transient hyperglycaemia) in patients with mycobacterium tuberculosis |
1. At Diagnosis
2. Three month after Diagnosis
3. End of treatment |
| To ascertain clinical differences in presentation of tubercular infection in patients with diabetes and glucose intolerance compared to those with normal glucose tolerance |
At Diagnosis
|
| To determine treatment response and final outcomes in patients with tubercular infection and glucose intolerance compared to those with normal glucose tolerance |
End of treatment |
|
|
Target Sample Size
|
Total Sample Size="1400"
Sample Size from India="1400"
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)
|
03/06/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study would help in understanding the best time for screening for glucose intolerance among patients with Tuberculosis and also give an estimate of the prevalence of glucose intolerance among patients with Tuberculosis |