| 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
|
|
|
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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