| CTRI Number |
CTRI/2024/10/075663 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on New Blood Markers for Identifying Non Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes |
|
Scientific Title of Study
|
A Clinical Study to Explore Novel Biomarkers for Predicting
Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes Mellitus Patients
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaista Ahmed |
| Designation |
PhD Scholar |
| Affiliation |
JAMIA HAMDARD |
| Address |
DEPARTMENT OF TRANSLATIONAL AND CLINICAL RESEARCH
South
DELHI
110062
India |
| Phone |
8076344457 |
| Fax |
|
| Email |
Shaistaahmed97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Ashif Khan |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
JAMIA HAMDARD |
| Address |
DEPARTMENT OF TRANSLATIONAL AND CLINICAL RESEARCH
South
DELHI
110062
India |
| Phone |
9891026397 |
| Fax |
|
| Email |
makhan@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineet Jain |
| Designation |
PROFESSOR |
| Affiliation |
Hakeem Abdul Hameed Centenary Hospital |
| Address |
Department of Medicine, Hakeem Abdul Hameed Centenary Hospital
South
DELHI
110062
India |
| Phone |
9999074056 |
| Fax |
|
| Email |
dr.vineet83@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi, 110062, India |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences
Jamia Hamdard, New Delhi,India-110062 |
| Type of Sponsor |
Research institution |
|
|
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 MOHD ASHIF KHAN |
Jamia Hamdard |
Department of translational and clinical research,3rd floor
South
DELHI |
9891026397
makhan@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E086||Diabetes mellitus due to underlying condition with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants with Diabetes defined as HbA1c less or equal to 6.5% or FPG 126mg/dL or taking anti-diabetic medication. |
|
| ExclusionCriteria |
| Details |
Individuals with a history of significant alcohol consumption-defined as more than 20 grams of alcohol per day for men and 10 grams per day for
women,Individuals with a history of other liver diseases, such as viral hepatitis, autoimmune
liver diseases, or liver cirrhosis,Pregnant individuals or those planning to become pregnant during the study period,Participants with severe comorbid conditions that could independently affect glucose metabolism or liver function (e.g., advanced chronic kidney disease, advanced heart
failure),Individuals taking medications known to significantly impact glucose metabolism
(e.g., corticosteroids) or liver function (e.g., methotrexate),Individuals with TB, any form of malignancies presents or history of HIV- AIDS or
any disease that could impair the biomarkers levels,Participants with a history of major psychiatric disorders or cognitive impairment.
Individuals currently taking medications that significantly impact glucose metabolism or biomarker levels (e.g., corticosteroids, certain antipsychotics),Individuals with a history of major surgery within the last six months,Individuals with acute infections or inflammatory conditions at the time of
recruitment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the serum levels of Biomarkers in all the 4 groups and to correlate them with NAFLD severity assessed by Fibro Scan. |
Single Time point (Baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To apply machine learning techniques to develop & validate predictive models for
NAFLD & T2DM based on serum biomarkers & clinical features, & to compare
their performance with conventional methods |
Single Time point(Baseline) |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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)
|
05/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
This study aims to investigate the intricate molecular mechanisms linking T2DM and NAFLD. |