| CTRI Number |
CTRI/2025/11/097802 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Screening for risk of Diabetes using a Simple score designed for Indian Population and Correlation with Blood tests |
|
Scientific Title of Study
|
Utility of Indian Diabetes Risk Score (IDRS) in screening for diabetes and correlation with biochemical parameters |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha Murthy |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of General Medicine, Junior Resident, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900811167 |
| Fax |
|
| Email |
anusha.murthy4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raviraja V Acharya |
| Designation |
Professor and Head of Unit |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of General Medicine, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
rvacharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anusha Murthy |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of General Medicine, Junior Resident, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900811167 |
| Fax |
|
| Email |
anusha.murthy4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 |
| Anusha Murthy |
Kasturba Hospital |
Department of General Medicine
Udupi
KARNATAKA |
9900811167
anusha.murthy4@gmail.con |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non diabetic individuals as inpatient or outpatient |
|
|
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 |
Individuals above age of 18
Individuals who give consent |
|
| ExclusionCriteria |
| Details |
1. Known cases of diabetes as per WHO criteria
2. Pregnant Women
3. Individuals on medication affecting glucose metabolism like steroids, immunosuppressants, antiretrovirals, antipsychotics.
4. Individuals with diseases affecting glucose metabolism like chronic liver disease, acute/chronic pancreatitis, Cushing’s syndrome, severe illnesses like sepsis and trauma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validation of the IDRS as an effective screening tool if a strong correlation with the biochemical parameters is demonstrated |
Validation of the IDRS as an effective screening tool if a strong correlation with the biochemical parameters is demonstrated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Prevalence of the population under study at high risk for diabetes based on age groups & lifestyle factors
|
At the end of study |
| 2. Early intervention measured for those who are pre diabetic or at moderate to high risk of developing diabetes |
Immediate |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
01/12/2025 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
This cross-sectional study aims to assess the effectiveness of the Indian Diabetes Risk Score (IDRS) as a screening tool for type 2 diabetes mellitus among non-diabetic individuals attending Kasturba Hospital, Manipal. After IEC approval, participants will be enrolled in the study with informed consent. They will be evaluated based on the factors of IDRS and classified into low, moderate and high risk of developing diabetes. The laboratory data of the routine blood investigations like fasting blood sugar (FBS), postprandial blood sugar (PPBS), HbA1c, fasting lipid profile (FLP) will be collected. Correlation between the score and the biochemical parameters will then by analysed using the statistical methods. Pre-diabetics who are detected in the study will be counselled regarding the risk of developing diabetes and to initiate lifestyle modifications. |