Elucidating Prevalence and Risk Determinants of Sarcopenia in Type 2 Diabetes Mellitus [SARC-T2DM]
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Sarcopenia prevalence using AWGS 2019 criteria
Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 60.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Sarcopenia prevalence using AWGS 2019 criteria
Time Frame: Single cross-sectional assessment at baseline
Secondary Outcomes
- 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)
Investigators
Dr Shobhit Raj
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal