| CTRI Number |
CTRI/2026/01/101367 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How fat to muscle mass ratio of a person is related with cardio metabolic risk factors in people with diabetes |
|
Scientific Title of Study
|
Association between fat to muscle mass ratio and cardio metabolic risk factors in type 2 diabetes mellitus |
| 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 Parminder Singh |
| Designation |
Professor |
| Affiliation |
SGRDIMSR Amritsar |
| Address |
Medicine department, unit 5
Amritsar
PUNJAB
143001
India |
| Phone |
8427264165 |
| Fax |
|
| Email |
docpammy9732@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parminder Singh |
| Designation |
Professor |
| Affiliation |
SGRDIMSR Amritsar |
| Address |
Medicine department, unit 5
Amritsar
PUNJAB
143001
India |
| Phone |
8427264165 |
| Fax |
|
| Email |
docpammy9732@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jasmeet Kaur Shergill |
| Designation |
Junior resident |
| Affiliation |
SGRDIMSR, AMRITSAR |
| Address |
Medicine department, unit 5 , SGRDIMSR
Amritsar
PUNJAB
143001
India |
| Phone |
9772156235 |
| Fax |
|
| Email |
shjasmeet2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Das institute of medical sciences and research Amritsar |
|
|
Primary Sponsor
|
| Name |
Department of Medicine |
| Address |
Shri Guru Ram Das Institute of Medical Sciences and Research, Vallah, Amritsar |
| Type of Sponsor |
Private medical college |
|
|
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 Parminder Singh |
Shri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
Department of medicine
Amritsar
PUNJAB |
8427264165
docpammy9732@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 and above
Patients who fulfil the diagnostic criteria of type 2 diabetes mellitus according to American diabetes association |
|
| ExclusionCriteria |
| Details |
Patient diagnosed with thyroid dysfunction
Patient diagnosed with type 1 diabetes mellitus
Patients who are morbid obese
Patient diagnosed with any malignancy
Patient with ascites
Patient with severe kidney dysfunction
Patient with implanted medical devices like pacemaker
All pregnant females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| High fat to muscle mass ratio is associated with increased cardio metabolic risk factors in type 2 diabetes mellitus |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased fat to muscle mass ratio is associated with increased cardio metabolic risk factors in people with type 2 diabetes |
On presentation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/01/2026 |
| 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="6"
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
|
To associate fat to muscle mass ratio and cardio metabolic risk factors with type 2 diabetes mellitus . Fat to muscle mass to be calculated using bio electric impedence device |