| CTRI Number |
CTRI/2025/08/093419 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find an early sign of diabetes by testing blood in healthy people, prediabetes, and diabetes patients. |
|
Scientific Title of Study
|
Circulating miR-223-3p: A Novel Marker for Early Detection and Glycemic Regulation 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 |
VISHWANATH MALKAPPA JALAWADI |
| Designation |
Assistant Professor |
| Affiliation |
BLDE Deemed to be university Shri BM Patil Medical College, Hospital and Research Centre |
| Address |
Department of Medicine
BLDE Deemed to be university
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
7856089869 |
| Fax |
|
| Email |
drvishwa.mj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VISHWANATH MALKAPPA JALAWADI |
| Designation |
Assistant Professor |
| Affiliation |
BLDE Deemed to be university Shri BM Patil Medical College, Hospital and Research Centre |
| Address |
Department of Medicine
BLDE Deemed to be university
Vijayapura
KARNATAKA
586103
India |
| Phone |
7856089869 |
| Fax |
|
| Email |
drvishwa.mj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VISHWANATH MALKAPPA JALAWADI |
| Designation |
Assistant Professor |
| Affiliation |
BLDE Deemed to be university Shri BM Patil Medical College, Hospital and Research Centre |
| Address |
Department of Medicine
BLDE Deemed to be university
Vijayapura
KARNATAKA
586103
India |
| Phone |
7856089869 |
| Fax |
|
| Email |
drvishwa.mj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri BM Patil Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil Medical College Hospital and Research Centre |
| Address |
Shri BM Patil Medical College Hospital and Research Centre BLDE Deemed to be University Vijayapura 586103 Karnataka India |
| 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 Vishwanath Malkappa Jalawadi |
Shri BM Patil Medical College Hospital and Research Centre |
Department of General Medicine
Bijapur
KARNATAKA |
7856089869
drvishwa.mj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SBMPMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
| Patients |
(1) ICD-10 Condition: E168||Other specified disorders of pancreatic internal secretion, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Body Mass Index (BMI) Between 18 point 5 and 30 kilograms per square meter
No history of chronic illnesses such as chronic kidney disease and coronary artery disease and asthma and others (except Type 2 Diabetes Mellitus in the case group)
No previous use of hypoglycemic drugs or insulin therapy (for prediabetes and Type 2 Diabetes Mellitus groups) |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
Patients on long term medication affecting glucose metabolism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expression levels of circulating miR 223 3p in healthy controls individuals with prediabetes and newly diagnosed T2DM patients and its correlation with glycemic parameters HbA1c fasting blood sugar insulin resistance. |
Assessed at baseline by fasting blood sample collection at enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
20/10/2025 |
| 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 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
|
This study aims to evaluate circulating miR 223 3p as a potential early biomarker for Type 2 Diabetes Mellitus. A total of 85 participants will be enrolled including healthy controls individuals with prediabetes and newly diagnosed T2DM patients. Blood samples will be analyzed for miR 223 3p expression using qRT PCR along with glycemic parameters such as HbA1c fasting blood sugar insulin and inflammatory markers. The study will investigate the association of miR 223 3p with glycemic regulation and insulin resistance. Findings are expected to support early detection improve preventive strategies and contribute to personalized diabetes management. |