Health Condition 1: M625- Muscle wasting and atrophy, not elsewhere classified Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Vitamin D3 supplementation: Oral cholecalciferol (Vitamin D3), 2000 IU daily for 12 weeks.
Intervention2: Resistance Training: Supervised bodyweight based resistance training program, t
Sponsors
J. Edward Arulswamy
Eligibility
Inclusion criteria
Inclusion criteria: Participants must meet all of the following: 1. Diagnosis of Type Two Diabetes Mellitus (T2DM): HbA1c greater than or equal to six point five percent (IDF 2025). 2. Sarcopenia, defined by Asian Working Group for Sarcopenia (AWGS) 2019 criteria: a. Low skeletal muscle mass (SMI less than seven point zero kilogram per meter square in men, less than five point seven kilogram per meter square in women). b. And low muscle strength (handgrip less than twenty eight kilogram in men, less than eighteen kilogram in women). c. Or low physical performance (gait speed less than zero point eight meter per second or chair stand greater than twelve seconds). 3. Age range: Forty to sixty years (targeting peak sarcopenia progression in T2DM). 4. Ambulatory status: Ability to perform functional tests and exercise interventions. 5. Women aged forty to sixty years with Type Two Diabetes Mellitus who are premenopausal, perimenopausal, or postmenopausal will be included, as estrogen decline during menopausal transition contributes to impaired muscle protein synthesis and mitochondrial dysfunction, increasing the risk and severity of sarcopenia in this population.
Exclusion criteria
Exclusion criteria: Participants will be excluded for any of the following: 1. Diabetes subtype: Type One Diabetes Mellitus or secondary diabetes. 2. Renal impairment: Chronic kidney disease with estimated glomerular filtration rate less than thirty milliliter per minute per one point seven three meter square. 3.Comorbidities: Active malignancy, recent fractures within six months, or hospitalization within three months. 4.Pharmacological confounders: a. Current vitamin D supplementation greater than one thousand International Units per day prior to study entry. b. Use of anabolic steroids. c. Use of statins. 5.Other exclusions: a. Pregnancy or lactation. b. Cognitive impairment or inability to provide informed consent. c. Contraindications to exercise such as cardiovascular or musculoskeletal conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in skeletal muscle index from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement. 2. Change in handgrip strength from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement. 3. Change in physical performance (gait speed and chair stand test) from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement.Timepoint: Baseline and twelve weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Hemoglobin A1c from baseline to twelve weeks among the four groups, with the combined intervention group expected to show greater reduction compared to the Vitamin D only group, the Resistance Training only group & the Control group. 2. Change in insulin resistance from baseline to twelve weeks assessed by Homeostatic Model Assessment for Insulin Resistance among the four groups, with the combined intervention group expected to show greater improvement compared to the Vitamin D only group, the Resistance Training only group & the Control group. 3. Correlation between serum Vitamin D levels & sarcopenia outcomes (skeletal muscle index, handgrip strength, physical performance) & glycemic outcomes (Hemoglobin A1c, insulin resistance) across all four groups. Timepoint: Baseline & twelve weeks | — |
Countries
India
Contacts
Public ContactDr K Prabhavathi MD
SRM Medical College Hospital and Research Centre
Outcome results
None listed