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CTRI Number  CTRI/2025/02/081309 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   observational study 
Study Design  Other 
Public Title of Study   Analysis of Body Composition and Functional Capacity in Different Stages of Metabolic Dysfunction Associated Steatohepatitis Patients 
Scientific Title of Study   Analysis of Body Composition and Functional Capacity in Different Stages of Metabolic Dysfunction Associated Steatohepatitis 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  RAMYA G 
Designation  Student 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research  
Address  Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra nagar,Porur,chennai

Chennai
TAMIL NADU
600116
India 
Phone  6369701457  
Fax    
Email  ramya097115@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  R Yogeshwari 
Designation  Lecturer 
Affiliation  Sri Ramachandra institute of higher education and research  
Address  Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra Nagar,Porur,chennai

Chennai
TAMIL NADU
600116
India 
Phone  9994360164  
Fax    
Email  yogeshwaridinakaran@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  R Yogeshwari 
Designation  Lecturer 
Affiliation  Sri Ramachandra institute of higher education and research  
Address  Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra nagar,porur,chennai

Chennai
TAMIL NADU
600116
India 
Phone  9994360164  
Fax    
Email  yogeshwaridinakaran@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
G Block hepatology and gastroenterology Sri Ramachandra Institute Of Higher Education And Research 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 Ramya G  Sri Ramachandra Institute Of Higher Education And Research   G Block Hepatalogy and gastroenterology, ground floor liver clinic 2B, Sri Ramachandra Institute Of Higher Education And Research , Faculty Of Physiotherapy, No.1 Ramachandra nagar,porur
Chennai
TAMIL NADU 
06369701457
45928693
ramya097115@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E889||Metabolic disorder, unspecified, (2) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age Above 18 yrs Both Male and Female Subjects Identified With NAFLD Confirmed Fibroscan Within Last 3 months CAP SCORE GREATER THAN OR EQUAL TO 238dB/m Indicating Hepatic Steatosis Liver Stiffness Measurement 7KPa or More  
 
ExclusionCriteria 
Details  musculoskeletal or neurological conditions affecting mobility
significant cardiovascular events or conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
body composition analyser
6MWT
HANDGRIP STRENGTH 
BASELINE AND 12 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
SKINFOLD MEASUREMENT  BASELINE AND 12 WEEKS 
 
Target Sample Size   Total Sample Size="145"
Sample Size from India="145" 
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)   05/03/2025 
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="0"
Months="3"
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  

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a new term used to describe steatotic liver disease linked to metabolic syndrome. MASLD is currently recognized as the most common cause of chronic liver disease and a major factor contributing to liver-related morbidity and mortality. Globally, the incidence and prevalence of nonalcoholic fatty liver disease (NAFLD), now a part of the MASLD spectrum, have risen, driven by the obesity epidemic, which affects populations worldwide, including in Korea. Research suggests that the prevalence of NAFLD in Asian countries is comparable to, and in some cases exceeds, that in Western countries. A study by Youn Huh et al. (2021) estimated that 15.82% of Asians were affected by NAFLD, based on criteria like hepatic steatosis or fatty liver index.NAFLD progresses through various stages, including fibrosis, cirrhosis, steatohepatitis, simple steatosis, and, in some cases, may even advance to hepatocellular carcinoma. In cases where only steatosis is present, the disease is relatively silent and follows a benign course (Puthija Kumaravalli et al., 2023). Mild hepatic steatosis, also known as grade 1 fatty liver, represents the least severe stage of NAFLD and involves minimal fat accumulation in liver cells. While often asymptomatic, it reflects the early onset of the disease.Studies indicate that patients with moderate to severe NAFLD are more likely to experience sarcopenia and show reduced muscle mass in both the trunk and lower limbs compared to those with mild NAFLD. Sarcopenia, characterized by a decline in muscle mass and strength, has become increasingly prevalent among older adults and individuals with severe illnesses like liver cirrhosis and cancer. Recently, the relationship between sarcopenia and MASLD has garnered significant attention. Prior research suggests that correcting muscle mass relative to height may underestimate the association between physical performance and muscle mass. Instead, BMI may provide a more accurate measure when considering body size, as it shows a stronger correlation with physical dysfunction and muscle weakness.the purpose of my study is to use a body composition analyzer to assess changes in fat and muscle mass across different stages of NAFLD. Using noninvasive tools like the BODY COMPOSITION ANALYZER MEDIANA, body composition analysis is now a practical method for evaluating individuals with NAFLD. However, there is limited clarity on measuring physical performance in these patients. Consequently, another objective of my study is to evaluate functional capacity using the 6-minute walk test (6MWT).By assessing changes in body composition and functional capacity at different stages of MASLD, this study aims to identify functional limitations that may accelerate disease progression. Early management strategies may help patients maintain or regain normal functioning, underscoring the importance of this research in improving patient outcomes.

 

 

 
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