| CTRI Number |
CTRI/2026/01/100180 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Evaluate the Relationship Between a Urinary Biomarker Synaptopodin and Kidney Function in Patients with Diabetic Kidney Disease |
|
Scientific Title of Study
|
Correlation of urinary glomerular podocyte biomarker - Synaptopodin levels with estimated glomerular filtration rate in diabetic nephropathy : An Observational Cross-Sectional study |
| 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 Naveena D |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka Missions Kirupanandha Variyar Medical College Hospitals |
| Address |
Department of General Medicine
Vinayaka Missions Kirupanandha Variyar Medical College Hospitals
Salem 636308 Tamil Nadu
Salem
TAMIL NADU
636308
India |
| Phone |
9790915060 |
| Fax |
|
| Email |
dnaveena@rocketmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S MOOGAAMBIGA |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupanandha Variyar Medical College Hospitals |
| Address |
Department of General Medicine
Vinayaka Missions Kirupanandha Variyar Medical College Hospitals
Salem 636308 Tamil Nadu
Salem
TAMIL NADU
636308
India |
| Phone |
9842459677 |
| Fax |
|
| Email |
mooks.stanlean@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveena D |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka Missions Kirupanandha Variyar Medical College Hospitals |
| Address |
Department of General Medicine
Vinayaka Missions Kirupanandha Variyar Medical College Hospitals
Salem 636308 Tamil Nadu
Salem
TAMIL NADU
636308
India |
| Phone |
9790915060 |
| Fax |
|
| Email |
dnaveena@rocketmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem 636308 Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Dr Naveena D |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem 636308 Tamilnadu India |
| Type of Sponsor |
Other [Self] |
|
|
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 Naveena D |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem 636308 Tamilnadu India |
Room number 16 Department of General medicine
Salem
TAMIL NADU |
9790915060
dnaveena@rocketmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Kirupanandha Variyar Medical College and Hospitals |
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 |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than thirty years and less than sixty years
Patients diagnosed with diabetes mellitus based on fasting blood sugar greater than one hundred and twenty six milligrams per decilitre or random blood sugar greater than two hundred milligrams per decilitre or glycated hemoglobin greater than six point five percent
Patients with estimated glomerular filtration rate less than sixty millilitres per minute per one point seven three square metres
Patients with urine albumin to creatinine ratio greater than or equal to thirty milligrams per gram of creatinine |
|
| ExclusionCriteria |
| Details |
Patients with coexisting hypertension along with diabetes mellitus
Patients aged less than thirty years and more than sixty years
Patients with established renal disease other than diabetic nephropathy
Patients with active urinary tract infection or systemic illnesses such as tuberculosis or human immunodeficiency virus infection
Patients with established autoimmune diseases such as systemic lupus erythematosus or immunoglobulin A nephropathy
Patients with tubular disorders including acute tubular necrosis and tubulointerstitial nephritis
Patients with acute or chronic exposure to nephrotoxic agents or medications including non steroidal anti inflammatory drugs angiotensin converting enzyme inhibitors angiotensin receptor blockers finerenone certain antibiotics such as aminoglycosides or chronic heavy metal exposure
Patients with acute stress conditions such as dehydration fever exercise or pregnancy
Patients with obstructive uropathy including renal tumours or renal calculi |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between urinary synaptopodin levels and estimated glomerular filtration rate in patients with diabetic nephropathy |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
12/01/2026 |
| 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="6"
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 common complication of diabetes and is a major cause of chronic kidney disease. Early detection of kidney damage is important to prevent disease progression. Damage to specialized kidney cells called podocytes occurs early in diabetic kidney disease, and proteins released from these cells may be detected in urine. Synaptopodin is a podocyte-specific protein that can be measured in urine and may serve as an early biomarker of kidney damage. This observational cross-sectional study aims to evaluate the relationship between urinary synaptopodin levels and kidney function in patients with diabetic nephropathy. Adult patients with diabetic nephropathy attending the study center will be included. Urine samples will be collected to measure synaptopodin levels, and blood samples will be used to assess kidney function using estimated glomerular filtration rate (eGFR). The correlation between urinary synaptopodin levels and kidney function will be analyzed, along with associations with disease severity and other clinical parameters. The findings of this study may help in understanding the role of urinary synaptopodin as a non-invasive biomarker for early detection and assessment of kidney damage in patients with diabetic nephropathy. |