| CTRI Number |
CTRI/2025/11/097671 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of blood parameters (Monocyte-to-HDL Cholesterol ratio) to assess the degree of Proteinuria (loss of protein in the urine) in patients with Pre-diabetes and Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Monocyte-to-HDL Cholesterol Ratio as a Marker of Proteinuria in Pre-Diabetes and 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 Shreya A Bhat |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine, KMC Manipal, Hebri Rd, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
6362069834 |
| Fax |
|
| Email |
shreyabhat221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Mukhyaprana Prabhu |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine, KMC Manipal, Hebri Rd, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
6362069834 |
| Fax |
|
| Email |
mm.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya A Bhat |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine, KMC Manipal, Hebri Rd, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
6362069834 |
| Fax |
|
| Email |
shreyabhat221@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KMC Manipal |
| Address |
Kasturba Hospital, Hebri Rd, Madhav nagar, Manipal, Udupi, Karnataka 576104 |
| 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 Shreya A Bhat |
Kasturba Hospital |
Baliga block, Kasturba Hospital, Hebri Road, Madhav Nagar, Udupi - 576104
Udupi
KARNATAKA |
6362069834
shreyabhat221@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Age more than or equal to 18 years
2) Patients who have HbA1c more than or equal to 5.6% OR a fasting glucose level of more than 126 mg/dl
3) Known diabetics/ pre-diabetics on treatment (lifestyle and/or medication) with good diabetic control, not meeting inclusion criteria 2.
|
|
| ExclusionCriteria |
| Details |
1) Patients who have other systemic diseases that may lead to proteinuria or impaired eGFR i.e
a. Acute infections
b. Chronic infections like HIV, Tb
c. Malignancies
d. Autoimmune disorders
e. Severe hepatic dysfunction
f. Congestive heart failure
g. Acute kidney injury
h. Uncontrolled hypertension (BP more than or equal to 140/90)
2) Type 1 diabetics
3) Patients in diabetic ketoacidosis or hyperosmolar nonketotic state |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proteinuria |
End of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| eGFR as a measure of renal function |
End of study |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
19/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The Monocyte-to-HDL cholesterol ratio is an emerging marker of inflammation, high values of which have been linked to metabolic syndrome, cardiovascular mortality and endothelial dysfunction. This ratio is of particular relevance in diabetic kidney disease due to its pathogenesis involving recruitment of monocytes, and the countering effect of HDL by inhibiting the proliferation and maturation of monocytes, making the MHR a reflection of the overall inflammatory milieu in the kidney in diabetics. Also, while proteinuria is a well-established marker of diabetic kidney disease, pre-diabetics have also been observed to develop proteinuria without decline in eGFR, thus prompting the possibility of pathological renal changes even in pre-diabetics, and promoting screening in this subset of the population.Patients will be recruited from the Department of Medicine. Following informed consent, they will be asked questions pertaining to their medical history and also undergo a basic physical examination for assessing BMI and vitals. For BP, the average of two recordings taken 15 minutes apart will be considered. They will then be asked to provide a fasting blood sample for fasting glucose, HbA1c, CBC, urea, creatinine, fasting lipid profile, and mid-stream urine sample for microscopy, routine analysis, random protein and random creatinine. Proteinuria will be assessed using UPCR. eGFR will be calculated using the 2021 CKD-EPI equation, and used as an outcome measure for decline in renal function. Patients will be divided into diabetic and pre-diabetic groups, and further sub-groups based on the degree of proteinuria. First, within the diabetic group, the researcher will assess the independent relations of diabetic control and MHR with proteinuria. Second, the degree of proteinuria and the MHR between diabetics and pre-diabetics will be compared. Third, the eGFRs of all subjects will be calculated and compared with the respective MHRs to detect any association between MHR and decline in renal function.
|