| CTRI Number |
CTRI/2024/02/062511 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on gut bacteria and diabetic retinopathy |
|
Scientific Title of Study
|
Diabetic Retinopathy Microbiome Study-India (DRMS-India) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBrijesh Takkar |
| Designation |
Consultant, Opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
Banjara Hills, Road No: 02
Hyderabad 500034
Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102124 |
| Fax |
|
| Email |
brijeshtakkar@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBrijesh Takkar |
| Designation |
Consultant, Opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
Banjara Hills, Road No: 02
Hyderabad 500034
Telangana, India
TELANGANA
500034
India |
| Phone |
04068102124 |
| Fax |
|
| Email |
brijeshtakkar@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrBrijesh Takkar |
| Designation |
Consultant, Opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
Banjara Hills, Road No: 02
Hyderabad 500034
Telangana, India
TELANGANA
500034
India |
| Phone |
04068102124 |
| Fax |
|
| Email |
brijeshtakkar@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute,
Banjara Hills, Road No: 02,
Hyderabad 500034, Telangana, India |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, Banjara Hills, Road No: 02, Hyderabad 500034, Telangana, India |
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
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 |
| DrBrijesh Takkar |
L V Prasad Eye Institute |
GPR Building, 1st floor, Room No:131, Clinical Research Department,Banjara Hills,
Road No:02, Hyderabad 500034
Telangana, India
Hyderabad
TELANGANA |
04068102124
brijeshtakkar@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Type 2 DM attending OPD of the institute with DM of onset at 30 years or older (WHO criteria).
2.Both insulin and OHA users
3.Morbidities associated with DM, CKD (chronic kidney disease), HTN (Hypertension), CAD (coronary artery disease), CVD (Cerebral vascular disease) and dyslipidemia with or without drug usage.
|
|
| ExclusionCriteria |
| Details |
1. Chronic health disorders other than those listed in inclusion.
2.Usage of oral drugs in the last 3 months for a period longer than a week
3.Usage of commercially marketed pre and probiotic dietary supplements in last 1 month
4.Any use of systemic antibiotic in the last one month |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gut microbiome index for diabetic retinopathy |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regional variation in gut microbiome in diabetic retinopathy across India |
3 years |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "539"
Final Enrollment numbers achieved (India)="539" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2024 |
| Date of Study Completion (India) |
06/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
DRMS is a pan-India project evaluating gut microbiome of Indians living in India with diabetes mellitus or diabetic retinopathy . Earlier studies have shown differences in diversity and abundance of the gut microbiome in people with or without DM, but in a lower sample size and in restricted ethnicity . DRMS-India would overcome these deficits and would also compare with healthy controls . It will create a biomarker for diabetic retinopathy |