| CTRI Number |
CTRI/2025/03/083688 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY TO ESTIMATE THE MAGNITUDE OF METABOLIC SYNDROME AND INSULIN RESISTANCE AMONG PERSONS FOUND TO HAVE SARCOPENIA AND SARCOPENIC OBESITY AT A TERTIARY HEALTH CARE CENTRE OF NORTH INDIA |
|
Scientific Title of Study
|
TO ESTIMATE THE MAGNITUDE OF METABOLIC SYNDROME AND INSULIN RESISTANCE AMONG SUBJECTS OF SARCOPENIA AND SARCOPENIC OBESITY AT A TERTIARY HEALTH CARE CENTRE OF NORTH INDIA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jarpala Prasad |
| Designation |
Junior Resident I |
| Affiliation |
GSVM Medical College, Kanpur |
| Address |
Department of Medicine, GSVM Medical College
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7675075101 |
| Fax |
|
| Email |
dr.prasad0143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Agarwal |
| Designation |
Professor |
| Affiliation |
GSVM Medical College, Kanpur |
| Address |
Room No 24
Department of Medicine
GSVM Medical College
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415039582 |
| Fax |
|
| Email |
dragarwalsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jarpala Prasad |
| Designation |
Junior Resident I |
| Affiliation |
GSVM Medical College, Kanpur |
| Address |
Department of Medicine, GSVM Medical College
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7675075101 |
| Fax |
|
| Email |
dr.prasad0143@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM MEDICAL COLLEGE,Swaroopnagar,Kanpur, INDIA-208002 |
|
|
Primary Sponsor
|
| Name |
GSVM Medical College Kanpur |
| Address |
Swaroop Nagar
Kanpur
INDIA 208002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MRU LAB |
GSVM Medical College,Kanpur
swaroopnagar,KANPUR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jarpala Prasad |
GSVM MEDICAL COLLEGE |
Room No 24
Department of Medicine
GSVM Medical College
Swaroop Nagar
Kanpur 208002
Kanpur Nagar
UTTAR PRADESH |
7675075101
dr.prasad0143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM Medical College , Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Presence of any of the following clinical conditions:
Sarcopenia as per Asian Working Group on Sarcopenia criteria 2019.
Sarcopenic Obesity
Subjects with any stable co-morbidity will be eligible to participate
|
|
| ExclusionCriteria |
| Details |
1.
Bed-ridden subjects due to anticipated problems in workup
2.
Pregnant and lactating females
3.
Acutely ill subjects
4.
Patients admitted to ICU
5.
Subjects with contraindication for MRI
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the magnitude of metabolic syndrome and insulin resistance among subjects of sarcopenia attending this tertiary health care facility. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)To find out the quality of life of subjects suffering from sarcopenia & sarcopenic obesity using Hindi validated version of SARQol questionnaire.
b)To find out the fracture risk of subjects suffering from sarcopenia & sarcopenic obesity using FRAX questionnaire.
c)To assess 10 year Cardiovascular Risk (Heart Attack & Stroke) with the help of ASCVD Plus score |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="233"
Sample Size from India="233"
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)
|
15/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
SARCOPENIA IS DEFINED as the loss of muscle mass and strength occurs naturally with aging. Other factors contribute to development of sarcopenia are physical inactivity, malnutrition and diseases such as neuro-degenerative diseases, endocrine disease or malignancy. Sarcopenia adds to the morbidity and mortality among patients with co-morbidity. Still, this remains an underdiagnosed entity. Associated metabolic syndrome adds to the probability of adverse outcome among these subjects. The data concerning this association is deficient in this part of the country. Therefore, this observational study will try to address the gap. We shall be including subjects with an age of 65 years and above having sarcopenia diagnosed according to the criteria of Asian Working Group for Sarcopenia and presence of metabolic syndrome will be confirmed on the basis of parameters given by NCEP ATP 3. Quality of life of the subjects enrolled will be determined by SARQOL Questionnaire permission for which has been taken. |