| CTRI Number |
CTRI/2025/12/098241 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand how body fat and muscle patterns affect liver and metabolic health in adults with Metabolic-Associated Steatotic Liver Disease (MASLD) |
|
Scientific Title of Study
|
Association of Adipose-Muscle Phenotypes with Clinical and Metabolic Parameters in Adult Patients with Metabolic-Associated Steatotic Liver Disease (MASLD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof NAVAL KISHORE VIKRAM |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 17, SRB Lab, 3rd Floor, Teaching block, Department of Medicine, New Delhi
New Delhi DELHI 110029 India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof NAVAL KISHORE VIKRAM |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 17, SRB Lab, 3rd Floor, Teaching block, Department of Medicine, New Delhi
New Delhi DELHI 110029 India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof NAVAL KISHORE VIKRAM |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 17, SRB Lab, 3rd Floor, Teaching block, Department of Medicine, New Delhi
New Delhi DELHI 110029 India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR)
V. Ramalingaswami Bhawan,
Ansari Nagar, Post Box No. 4911,
New Delhi – 110029,
Delhi, India. |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Naval K Vikram |
All India Institute of Medical Sciences, New Delhi |
Room No A-209, Department of Medicine, New RAK OPD, Ansari Nagar, New Delhi, Delhi, 110029 New Delhi DELHI |
01126593678
navalvikram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, ANSARI NAGAR, DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years, Diagnosed with MASLD, Willing to give informed consent, BMI above 18.5 |
|
| ExclusionCriteria |
| Details |
Known case or recently diagnosed diabetes mellitus, Participants who have undergone any recent major surgery in the last three months, Any acute or chronic infectious illness, History of pancreatitis or any other diseases requiring dietary modifications or restrictions, Chronic liver, heart and kidney disease, osteoarthritis and advanced end organ damage, Pregnant and lactating women, Presence of seropositivity for Hepatitis B, C and Human Immunodeficiency Virus, Excessive alcohol use more than 20 g per day for women and more than 30 g per day for men, Intake of any anti obesity drugs like orlistat, liraglutide, etc. currently or in the last three months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| identification of significant associations between Adipose-Muscle Phenotypes characterized by variations in visceral fat and lean mass and clinical and metabolic parameters in MASLD patients |
One time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| identification of a significant association between adipose- phenotypes characterized by variation in visceral fat and lean mass - and muscle strength, eating behaviour, sleep quality, and physical activity |
One Time study |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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)
|
15/12/2025 |
| 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="3" 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
|
Rationale:
MASLD is a growing global health concern, strongly linked to obesity, insulin
resistance, and systemic inflammation. However, obesity is a heterogeneous
condition, and patients with similar BMI may exhibit varying fat distribution
and muscle mass, influencing MASLD progression. Current diagnostic criteria
overlook these variations, leading to misclassification of disease risk and
suboptimal management strategies. Understanding these differences is crucial
for improving disease assessment and therapeutic interventions.
Novelty:
This study investigates distinct Adipose-Muscle Phenotypes in MASLD patients,
an under-explored area. Unlike traditional BMI-based classifications, it
emphasizes visceral fat, lean mass, and their interplay in disease progression.
It integrates muscle strength, sleep quality, eating behavior, and physical
activity to provide a comprehensive metabolic health assessment. This approach
could redefine risk stratification and therapeutic strategies for MASLD.
Objectives:
The objective is to examine the association between Adipose-Muscle Phenotypes,
categorized based on visceral fat and lean mass levels, clinical and metabolic
parameters in MASLD patients. The study also aims to compare muscle strength,
quality of life, sleep quality, eating behavior, physical activity across these
phenotypes.
Methods:
This cross-sectional observational study will recruit 400 MASLD patients (100
each group) at AIIMS, New Delhi. Body composition will be assessed using BIA
scan, liver steatosis and fibrosis will be evaluated through FibroScan.
Biochemical markers, muscle strength, and quality of life will also be analysed.
Expected Outcome:
The study aims to establish associations between Adipose-Muscle Phenotypes and
clinical/metabolic parameters in MASLD. Findings could enhance patient
stratification and guide personalized treatment strategies, improving long-term
metabolic and hepatic outcomes. |