| CTRI Number |
CTRI/2022/04/042201 [Registered on: 27/04/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
MAFLD and Sarcopenia and heart disease risk |
|
Scientific Title of Study
|
A study of association of Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) and dynapenia/sarcopenia with cardio-metabolic risks |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naval Kishore Vikram |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 8, SRB Lab, 3rd Floor, teaching block, Department of Medicine
New Delhi
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naval Kishore Vikram |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 8, SRB Lab, 3rd Floor, teaching block, Department of Medicine
New Delhi
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naval Kishore Vikram |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 8, SRB Lab, 3rd Floor, teaching block, Department of Medicine
New Delhi
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
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 Kishore Vikram |
All India Institute of Medical Sciences, New Delhi |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, 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 |
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 |
Adults of age 18-60 years, with fatty liver disease
Obese/Overweight individuals
Type 2 Diabetes Mellitus
Metabolically dysregulated Lean body individuals
Hand grip strength Men <28 kg, Women <18 kg
Appendicular skeletal muscle mass/height2
: Men<7.0kg/m2, Women <5.4 kg/m2.
SPPB≤8 (The maximum score on the SPPB is:12)
4-minute gait speed <0.8m/s.
|
|
| ExclusionCriteria |
| Details |
Pregnant women
Patient denying consent
Cirrhotic liver disease patients
Pediatric population |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ASCVD risk score, Prevalence of dynapenia and sarcopenia in
MAFLD subjects.
• metabolic parameters, insulin resistance and subclinical
inflammation |
one time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
metabolic parameters, insulin resistance and subclinical
inflammation
|
ONE TIME |
|
|
Target Sample Size
|
Total Sample Size="1100"
Sample Size from India="1100"
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)
|
16/05/2022 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 16-05-2025 and end date provided 16-05-2030?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background: The presence of sarcopenia is regarded as an important indicator of the
severity and prognosis of NAFLD, which might be extrapolated into MAFLD because of
its substantial overlap with NAFLD. The severity of NAFLD is associated with ASCVD
risk, independently of other cardiovascular risk factors. Based on these prognostic
implications of liver fibrosis and ASCVD in patients with NALFD, the severities of these
two factors might also differ among subgroups of patients according to MAFLD severity.
• Novelty: The study will examine the association of dynapenia/sarcopenia in MAFLD
with cardio-metabolic risks which is the first study in India.
• Objectives: To assess the association of Metabolic Dysfunction Associated Fatty Liver
Disease (MAFLD) and dynapenia/sarcopenia with cardio-metabolic risks. Another
objective is to assess the prevalence of dynapenia and sarcopenia in subjects with MAFLD,
to assess the association of liver fibrosis and steatosis in subjects with dynapenia and
sarcopenia in MAFLD through non-invasive methods (FIB4, NFS and Fibroscan) and to
assess the risk of dynapenia and sarcopenia in subjects with MAFLD and its association
with various lifestyle, anthropometric and biochemical factors.
• Methods: The study is observational with cross-sectional study design. Subjects attending
Medicine OPD will be screened for MAFLD, followed by Dynapenia/Sarcopenia.
• Expected outcome: There will be significant association between MAFLD, Dynapenia or
sarcopenia and ASCVD. The risk of ASCVD may be higher in subjects having both
MAFLD and dynapenia/sarcopenia. |