| CTRI Number |
CTRI/2024/08/072370 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Urinary Risk Indicators for Novel Evaluation of Diabetic Kidney Disease in type 2 diabetes |
|
Scientific Title of Study
|
Prognostic Potential of Novel Urinary Biomarkers Combination for Predicting Progression of Diabetic Kidney Disease in Type 2 Diabetes Mellitus |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan V Bhojaraja |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan V Bhojaraja |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar Prasad N |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Room 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739905443 |
| Fax |
|
| Email |
shankar.prasad@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
manipal.edu, Manipal 576104, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mohan V Bhojaraja |
Kasturba Medical College, Manipal |
Sharda Pai OPD, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9902548725
mohan.vb@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N181||Chronic kidney disease, stage 1, (2) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (3) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive adult patients (age ≥ 18 years). Clinically Diagnosed with CKD as per KDIGO guidelines (CKD stage 1-3) based on CKD-EPI equation in type 2 DM visiting the out-patient clinics of the department of Nephrology, Endocrinology and Medicine. |
|
| ExclusionCriteria |
| Details |
Those with CKD stage 4-5, urinary tract infection, inflammatory disorder, allergic disorder, cancer, autoimmune disorder, CKD plus superimposed with non-DM kidney disease, systemic connective tissue disorder and those under nephrotoxic medication. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rapid decline of GFR |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Worsening of proteinuria |
1 year |
| Onset of diabetic retinopathy or peripheral neuropathy |
6 months |
| Onset of Cardiovascular diseases or coronary artery diseases or peripheral vascular disease |
6 months |
| Mortality |
1 year |
|
|
Target Sample Size
|
Total Sample Size="145"
Sample Size from India="145"
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)
|
16/09/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
The study aims to observe the predictive potential of the seven urinary biomarkers panel, namely Cystatin C, KIM-1, NGAL, TNF-α, MCP-1, CTGF, and TGF-β in patients with diabetic kidney disease and type 2 diabetes mellitus. In this study, the patients will be recruited from this hospital, and the levels of these seven biomarkers will be measured at the time of recruitment from their urine samples. Further, the patients will be observed for one year for rapid progression of DKD or rapid decline of GFR. The patients will also be monitored for proteinuria, micro- or macro-vascular complications, or even patient mortality. |