| CTRI Number |
CTRI/2025/07/091672 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Genetics in High Blood Sugar Patients |
|
Scientific Title of Study
|
Genetic Study of Transcription Factor 7 Like 2 (TCF7L2) Gene Polymorphism 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 |
Dr. Sankranthi Rajasekhar |
| Designation |
Junior Resident cum Post Graduate Department of Medicine |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Room No 309, Department of Medicine, BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
(586103),India.
Bijapur
KARNATAKA
586103
India |
| Phone |
8333874833 |
| Fax |
|
| Email |
rajasankranti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Badiger Sharanabasawappa |
| Designation |
Professor Department of Medicine |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Room No 309, Department of Medicine, BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
(586103), India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448434927 |
| Fax |
|
| Email |
sharanrb@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Badiger Sharanabasawappa |
| Designation |
Professor Department of Medicine |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
| Address |
Room No 309, Department of Medicine, BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura,
Karnataka
(586103), India
Bijapur
KARNATAKA
586103
India |
| Phone |
9448434927 |
| Fax |
|
| Email |
sharanrb@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
(586103), India. |
|
|
Primary Sponsor
|
| Name |
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre |
| Address |
BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
(586103), India. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sankranthi Rajasekhar |
Room No 309, Department of Medicine, BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, vijayapura, Karnataka
(586103), India.
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sankranthi Rajasekhar |
BLDE Deemed to be University Shri B M Patil Medical College, Hospital and Research Centre |
Room No 309, Department of Medicine, BLDE (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre, Vijayapura, KARNATAKA,
(586103), India.
Bijapur
KARNATAKA |
8333874833
rajasankranti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMAN VOLUNTEERS WITHOUT TYPE 2 DIABETES |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients Admitted/ Attending OPD with Type 2 Diabetes Mellitus. |
|
| ExclusionCriteria |
| Details |
1. Patients with Type 1 Diabetes Mellitus.
2. Patients with Thyroid Disorders.
3. Patients with Polycystic Ovary Disease.
4. Patients with Gestational Diabetes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO identify the individual risk of TCF7L2 gene mutation in patients with type 2 diabetes mellitus. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will be helpful for the development of biomarkers for clinicians & the community. By using the study’s aggregated data for early detection of type 2 diabetes mellitus & early intervention, the burden of disease in terms of morbidity & mortality of disease will be reduced. |
12 month |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
04/08/2025 |
| 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 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
|
THIS STUDY IS A CASE-CONTROL STUDY OF TRANSCRIPTION FACTOR 7-LIKE 2 (TCF7L2) GENE POLYMORPHISM IN HOSPITAL PATIENTS WITH TYPE 2 DIABETES MELLITUS. IT WILL BE CONDUCTED IN BLDE (DEEMED TO BE UNIVERSITY) SHRI B.M. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA. TOTAL OF 164 PEOPLE (82 PATIENTS AND 82 HEALTHY CONTROLS) WILL BE TAKEN INTO THIS STUDY AFTER APPLYING THE INCLUSION AND EXCLUSION CRITERIA. THE PRIMARY OUTCOME OF THE STUDY IS TO DETECT THE RISK OF THE TCF7L2 GENEPOLYMORPHISM IN PATIENTS WITH TYPE 2 DIABETES MELLITUS. THE SECONDARY OUTCOME OF THE STUDY WILL BE HELPFUL TO THE DEVELOPMENT OF BIOMARKERS FOR THE CLINICIAN AND THE COMMUNITY. BY USING THE STUDY’S AGGREGATED DATA FOR THE EARLY DETECTION OF THOSE AT RISK FOR TYPE 2 DIABETES MELLITUS AND EARLY INTERVENTION, THE BURDEN OF DISEASE IN TERMS OF MORBIDITY AND MORTALITY OF DISEASE WILL BE REDUCED. |