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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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