| CTRI Number |
CTRI/2025/12/098452 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The number of patients with metabolic syndrome who also suffer from weak or low muscle mass |
|
Scientific Title of Study
|
Proportion of patients with metabolic syndrome suffering from comorbid sarcopenia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chetan Bhasin |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09560641684 |
| Fax |
|
| Email |
chetanbhasin3005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivashankara K N |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09448623861 |
| Fax |
|
| Email |
shi.sha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shivashankara K N |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09448623861 |
| Fax |
|
| Email |
shi.sha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, Kasturba Medical College, Manipal |
| Department of Physiotherapy, Manipal College of Health Professions, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Medicine OPD, Department of General Medicine, Kasturba Medical College, Manipal |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Physiotherapy |
Manipal College Of Health Professions, Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chetan Bhasin |
Kasturba Hospital |
Medicine OPD A and B, Department of General Medicine
Udupi
KARNATAKA |
09560641684
chetanbhasin3005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E70-E88||Metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults more than or equal to 20 years of age with Metabolic syndrome, both genders |
|
| ExclusionCriteria |
| Details |
Stroke
Malignancy
Tuberculosis
Heart Failure
Chronic Kidney disease
Chronic Liver disease
Hyper and hypothyroidism
Chronic inflammatory conditions
Chronic muscle wasting diseases
HIV
Rheumatological conditions
Osteoporosis
Neurodegenerative disorders like Parkinsonism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of metabolic syndrome patients classified as sarcopenic based on low muscle mass using bioelectrical impedance analysis, low muscle strength using hand grip dynamometry, and/or low physical performance using five times sit to stand test with a standard chair at baseline
|
cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="119"
Sample Size from India="119"
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)
|
18/12/2025 |
| 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="1"
Months="4"
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
|
Eligible participants will be screened based on the inclusion and exclusion criteria. Those who meet the criteria will be recruited into the study. The study procedures will be explained to the selected participants, and written informed consent will be obtained. At baseline, participants will be assessed for relevant components of metabolic syndrome and sarcopenia. Sarcopenia assessment will include measurement of calf circumference using a flexible measuring tape, muscle strength using hand grip dynamometry, and physical performance using the five times sit to stand test with a standard chair. Test can be performed either in the outpatient department or in the ward, depending on participant location. |