| CTRI Number |
CTRI/2025/03/082377 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To determine Tumor necrosis factor receptor 1 (TNFR1)levels in type 2 diabetes mellitus(T2DM)and its association with levels of proteinuria |
|
Scientific Title of Study
|
Tumor necrosis factor receptor 1(TNFR1) levels in type 2 diabetes mellitus(T2DM)and its association with levels of proteinuria |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajat Rao |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College,New Delhi |
| Address |
Room no 126 ,1st floor, medicine department, BL Taneja block, MAMC, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8708595225 |
| Fax |
|
| Email |
rajatrao998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Kumar |
| Designation |
Professor |
| Affiliation |
MAMC Delhi |
| Address |
Room no 126 ,1st floor, medicine department, BL Taneja block, MAMC, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9910555433 |
| Fax |
|
| Email |
pradeepkumar.pacific@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Rao |
| Designation |
Post graduate |
| Affiliation |
MAMC Delhi |
| Address |
Room no 126 ,1st floor, medicine department, BL Taneja block, MAMC, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8708595225 |
| Fax |
|
| Email |
rajatrao998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated LN,GIPMER and GNEC Hospitals, New Delhi ,110002,India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and associated LN,GIPMER and GNEC Hospitals, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Rajat Rao |
Lok Nayak Hospital |
Maulana Azad Medical College and associated LN,GIPMER and GNEC Hospitals, New Delhi
New Delhi
DELHI |
8708595225
rajatrao998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated LN,GIPMER and GNEC Hospitals, New Delhi ,110002,India , Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed type 2 diabetes mellitus greater than 40 years of age |
|
| ExclusionCriteria |
| Details |
Chronic inflammatory conditions (SLE, RA,Psoriasis, Pyomyositis),heart failure, MI,Sepsis, pregnancy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Measurement of tumor necrosis factor receptor 1(TNFR1)levels in type 2 diabetes mellitus
To measure levels of proteinuria in type 2 diabetes mellitus with tumor necrosis factor receptor 1 |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of glycemic parameters with tumor necrosis factor receptor 1 |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetic patients are at high risk of developing nephropathy (proteinuria). My study would detect association of levels of proteinuria with Tumor necrosis factor receptor 1 levels in type 2 diabetes mellitus. It helps in early detection of nephropathy in Type 2 diabetes mellitus patients. |