| CTRI Number |
CTRI/2026/02/104015 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study The Role Of KIM-1 And NGAL : Biomarker Based Prediction Of Diabetic Nephropathy |
|
Scientific Title of Study
|
To Study The Role Of KIM-1 And NGAL Biomarker Based Prediction Of Renal Injury In Type 2 Diabetic Nephropathy |
| 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 Mudhkede Shivam Sanjay |
| Designation |
PG student |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9619338876 |
| Fax |
|
| Email |
shivamonly7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arif Maldar |
| Designation |
Professor |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of General Medicine
Jawaharlal Nehru Medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
08312471350 |
| Fax |
|
| Email |
arifmaldar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mudhkede Shivam Sanjay |
| Designation |
PG student |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College
Belagavi
KARNATAKA
590010
India |
| Phone |
9619338876 |
| Fax |
|
| Email |
shivamonly7@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital & Medical Research Centre
Department Of General Medicine
Nehru Nagar, Belagavi, Karnataka, India 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Shivam Sanjay Mudkhede |
| Address |
Department Of General Medicine
Jawaharlal Nehru Medical College
Nehru Nagar, Belagavi, Karnataka 590010 |
| Type of Sponsor |
Private 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 Mudkhede Shivam Sanjay |
Dr KLE Prabhakar Kore hospital |
Department Of General Medicine Jawaharlal Nehru Medical College, Belagavi – 590010 Karnataka, India
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9619338876
shivamonly7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC 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 |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged between 18 and 80 years
Diagnosed cases of Type 2 Diabetes Mellitus (T2DM) as per American Diabetes Association criteria
Willingness to participate and provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patients with chronic kidney disease (CKD) due to causes other than diabetic nephropathy like glomerulonephritis, polycystic kidney disease, obstructive uropathy
Acute kidney injury or any recent acute illness affecting renal function
Active urinary tract infections
Current or recent use of nephrotoxic drugs, such as prolonged use of nonsteroidal anti-inflammatory drugs, aminoglycosides, or contrast agents
History of malignancy or undergoing chemotherapy
Patients with severe liver disease, heart failure, or other systemic inflammatory conditions.
Pregnant or lactating women
Age below 18 years or above 80 years
Refusal to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation between Urinary Biomarkers (KIM 1, NGAL) and the severity of renal impairment and to identify the most sensitive and specific biomarker for early detecting of diabetic nephropathy. |
On the day of diagnosis day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
14/03/2026 |
| 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 Nephropathy is a leading cause of Chronic Kidney Disease and End Stage Renal Disease and its detection is crucial for timely intervention and prevention of progression to end stage renal disease. So incorporating these biomarkers such as NGAL and KIM-1 is essential and help in better outcomes in patients with type 2 diabetes mellitus. |