CTRI

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CTRI Number

CTRI/2025/04/084813 [Registered on: 15/04/2025] Trial Registered Prospectively

Last Modified On:

11/04/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

To find out how many of the elderly persons attending a tertiary care hospital are suffering from Sarcopenic Obesity in North India.

Scientific Title of Study

To estimate the magnitude Of sarcopenic obesity among elderly subjects attending a tertiary health care center 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 Sonam Yadav
Designation	Junior Resident
Affiliation	GsvmMedical College, Kanpur
Address	Room Number 24 Department Of Medicine Gsvm Medical College Kanpur Kanpur Nagar UTTAR PRADESH 208002 India
Phone	9999004376
Fax
Email	doctorsonam03091995@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Saurabh Agarwal
Designation	Professor
Affiliation	GSVM Medical College, Kanpur
Address	Room Number 24 Department Of Medicine GSVM Medical College Kanpur Kanpur Nagar UTTAR PRADESH 208002 India
Phone	9415039582
Fax
Email	dragarwalsaurabh@gmail.com

Details of Contact Person
Public Query

Name	Dr Saurabh Agarwal
Designation	Professor
Affiliation	GSVM Medical College, Kanpur
Address	Room Number 24 Department Of Medicine GSVM Medical College Kanpur Kanpur Nagar UTTAR PRADESH 208002 India
Phone	9415039582
Fax
Email	dragarwalsaurabh@gmail.com

Source of Monetary or Material Support

GSVM Medical College, Kanpur, Uttar Pradesh, India-208002

Primary Sponsor

Name	GSVM Medical College
Address	Swaroop Nagar Kanpur, Uttar Pradesh India 208002 Pincode- 208002
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
MRU LAB

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Saurabh Agarwal	GSVM Medical College	Room No 24 Department of Medicine LLR Hospital Kanpur Nagar UTTAR PRADESH	9415039582 dragarwalsaurabh@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type

Condition

Patients

(1) ICD-10 Condition: K721||Chronic hepatic failure, (2) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (3) ICD-10 Condition: I509||Heart failure, unspecified, (4) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (5) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, (6) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (7) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (8) ICD-10 Condition: E669||Obesity, unspecified, (9) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	60.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	Age more than 60 years both male and female BMI more than 25 g/m2 coming to outpatient department at tertiary care centers Normal healthy subjects and subjects suffering from any chronic stable co-morbid condition (heart failure, chronic obstructive pulmonary disease, diabetes mellitus, chronic kidney disease, Chronic Liver Disease etc) with Functional decline or limitation Unintentional weight loss Depressive mood Cognitive impairment Repeated falls Malnutrition SARC-F equal to or more than 4 or SARC-CalF equal to or more than 11

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
6. Malignancy

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
To Estimate the magnitude of Sarcopenic Obesity in Elderly subject attending a tertiary care centre of North India.	Baseline

Secondary Outcome

Outcome	TimePoints
1.To assess the magnitude of Metabolic Syndrome among subjects with sarcopenic obesity. 2.To assess the magnitude of insulin resistance among subjects with sarcopenic obesity. 3.Impact of sarcopenic obesity on Quality of Life using SARQoL 4.To assess 10year Cardiovascular Risk (Heart Attack&Stroke) with the help of ASCVD Plus Score.	Baseline

Target Sample Size

Total Sample Size="96"
Sample Size from India="96"
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)

30/04/2025

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="1"
Months="0"
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

Sarcopenia Is a Common Health Condition Well Recognised Internationally. It has a direct impact on Quality of life And tendency to fall And Increased Mortality . While Treating the Condition no efforts are made to diagnose the presence of Sarcopenia . The condition can be treated with Nutritional Supplement And Excercise with improved outcomes. Not much Data Is Present in This Part of The Country. Hence, this study will be conducted to find the Magnitude of Sarcopenia.