| CTRI Number |
CTRI/2025/10/096693 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Burden of type 2 diabetes mellitus amongst the first degree relatives of known diabetic patients |
|
Scientific Title of Study
|
Burden Of Type 2 Diabetes Mellitus Amongst The First-Degree Relative Of Known Diabetic Patients at Tertiary care center:
A Cross -Sectional Study in Jaipur |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRaheesh |
| Designation |
Junior Resident |
| Affiliation |
Ruhscms Jaipur |
| Address |
room number 605 ,residence hostel ,Ruhs medical college ,jaipur
Bill Karendi teh tapukara district Khairthal-tijara
Alwar
RAJASTHAN
302033
India |
| Phone |
9660509888 |
| Fax |
|
| Email |
Khanraheesh78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaseem Naheed baig |
| Designation |
Head of department |
| Affiliation |
Ruhs cms |
| Address |
First floor department of community medicine ,Ruhs college of medical sciences,Jaipur..
Jaipur
RAJASTHAN
302033
India |
| Phone |
9828347157 |
| Fax |
|
| Email |
drvaseemnaheed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vaseem naheed baig |
| Designation |
Head of department |
| Affiliation |
Ruhs cms |
| Address |
First floor department of community medicine ,Ruhs college of medical sciences,Jaipur..
Jaipur
RAJASTHAN
302033
India |
| Phone |
9828347157 |
| Fax |
|
| Email |
drvaseemnaheed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ruhs medical college ,Jaipur 302033 |
|
|
Primary Sponsor
|
| Name |
Ruhs college of medical sciences |
| Address |
Ruhs college of medical sciences ,para tap nagar ,Jaipur 302033 |
| Type of Sponsor |
Government 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 raheesh |
Ruhs college of medical sciences |
Ncd clinic ,Ruhs college of medical science ,Sector 11 ,pratap nagar kumbha marg ,jaipur 302033
Jaipur
RAJASTHAN |
9660509888
Khanraheesh78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS-CMS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
First degree relatives of known diabetics
More than 18 years and of both sexes
Participants willing to give consent |
|
| ExclusionCriteria |
| Details |
Already diagnosed family members (attendants) with Type 2 Diabetes Mellitus.
Individuals with Type 1 Diabetes mellitus cases.
Patients diagnosed with Gestational Diabetes Mellitus.
Individuals on steroid/immunosuppressive therapy/ antipsychotic /anti-cancer drugs
Significant comorbidities impacting study outcomes. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the burden of type 2 diabetes amongst the first-degree relatives of diagnosed DM2 patients. |
till 1yr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate risk factors contributing to diabetes development in first-degree relatives by Indian Diabetic Risk Score (IDRS) |
1year |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
11/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Khanraheesh78@gmaiil.com].
- For how long will this data be available start date provided 28-12-2024 and end date provided 28-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The study aims to analyze the burden of diabetes among the family members of known diabetics.AIM: This study determines the burden of type 2diabetes amongst the first-degree relatives of known type 2 diabetes mellitus individuals. OBJECTIVES: Primary Objective: 1. To determine the burden of type 2 diabetes amongst the first-degree relatives of diagnosed DM2 patients. Secondary Objective: 1. To identify socio-demographic variables amongst first-degree relatives. 2. To investigate risk factors contributing to diabetes development in first-degree relatives by Indian Diabetic Risk Score (IDRS). |