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CTRI Number  CTRI/2025/10/096065 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   How common is muscle loss and what factors increase risk in people with type 2 diabetes 
Scientific Title of Study   Elucidating Prevalence and Risk Determinants of Sarcopenia in Type 2 Diabetes Mellitus [SARC-T2DM] 
Trial Acronym  SARC-T2DM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shobhit Raj 
Designation  PhD - Research Scholar 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Endocrinology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7004260830  
Fax    
Email  shobhit.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sahana Shetty 
Designation  Professor and Head of Department 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Endocrinology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9944745014  
Fax    
Email  sahana.shetty@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shobhit Raj 
Designation  PhD - Research Scholar 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Endocrinology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7004260830  
Fax    
Email  shobhit.kmcmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal Udupi District Karnataka - 576104 India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shobhit Raj  Kasturba Medical College, Manipal  Department of Endocrinology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi District Karnataka - 576104 India
Udupi
KARNATAKA 		 7004260830

shobhit.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus, (2) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults aged 60 years or above with established type 2 diabetes mellitus as per WHO criteria, attending Endocrinology outpatient department at Kasturba Hospital Manipal, willing to provide written informed consent. 
 
ExclusionCriteria 
Details  Acute illness or hospitalization within 4 weeks, malignancy, chronic kidney disease with eGFR less than 30, chronic liver disease, inflammatory conditions such as rheumatoid arthritis or inflammatory bowel disease, medications affecting muscle mass including corticosteroids for more than 3 months or chemotherapy, physical disabilities preventing functional assessments, pregnancy or lactation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sarcopenia prevalence using AWGS 2019 criteria  Single cross-sectional assessment at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Risk factors demographic, clinical, and biochemical  Single cross-sectional assessment at baseline 
Quality of life scores using SarQoL and EQ-5D-5L  Single cross-sectional assessment at baseline 
Metabolomic signatures in case-control comparison  Single cross-sectional assessment at baseline 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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)   20/10/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This is a prospective cross-sectional study designed to determine the prevalence and risk determinants of sarcopenia among Indian adults aged 60 years or above with type 2 diabetes mellitus. The study will recruit 260 participants from the Endocrinology outpatient department at Kasturba Hospital, Manipal, using consecutive sampling. Sarcopenia will be diagnosed using the Asian Working Group for Sarcopenia 2019 criteria, which is validated for Asian populations and considered the gold standard. Assessment will be conducted through a single visit lasting 45 to 60 minutes, including handgrip dynamometry for muscle strength, dual energy X-ray absorptiometry scan for muscle mass measurement, physical performance tests including 5-time chair stand or 6-meter walk test, and quality of life assessment using the sarcopenia-specific SarQoL questionnaire and generic EQ-5D-5L instrument in English or Kannada versions. A nested case-control component will include 30 sarcopenic and 30 non-sarcopenic participants matched by propensity scores for metabolomic profiling using gas chromatography-mass spectrometry to identify dysregulated metabolic pathways and novel biomarkers. This will be the first Indian study to perform metabolic profiling in sarcopenic type 2 diabetes patients. The study aims to identify modifiable clinical and demographic risk factors, assess quality of life deficits, and contribute evidence for integrating sarcopenia screening into national diabetes management guidelines. Data will be analyzed using descriptive statistics, binary logistic regression for risk factor analysis, Mann-Whitney U tests for quality of life comparisons, and propensity score matching for metabolomic case-control analysis. The estimated study duration is 2 years and 6 months.

 
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