HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: muscle, lean_mass, nutrition
- Who it enrolls
- age 65 Years to 85 Years; no BMI minimum stated; conditions: Type 2 Diabetes Mellitus (T2DM); Sarcopenia; Obesity; Muscle Loss
- Interventions
- Calcium-HMB Plus Vitamin D3; Matching placebo
- Conditions
- Type 2 Diabetes Mellitus (T2DM); Sarcopenia; Obesity; Muscle Loss; Older Adults
- Phase and size
- Phase 2 · 90 participants
- Dates
- Start 2026-12-01
Primary completion 2029-11-30 - Sponsor
- Vanderbilt University Medical Center (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in Appendicular Lean MassBaseline to month 6
02Eligibility
Who can take part
Inclusion Criteria: * Age 65 to 85 years, inclusive. * Type 2 diabetes mellitus, defined by HbA1c at or above 6.5% or current use of antihyperglycemic medication. * Body mass index at or above 27 kg/m2. * Newly initiating semaglutide as standard clinical care under the direction of a treating clinician. * Able to walk 400 meters without assistance; use of a cane is permitted. * Able to understand and provide legally effective informed consent. * English speaking for the initial study because the consent documents, questionnaires, study-product instructions, safety instructions, and procedure-specific materials are available only in English. Exclusion Criteria: * Estimated glomerular filtration rate below 45 mL/min/1.73 m2. * Use of HMB, creatine, or high-dose whey protein supplements within the previous 3 months. * Weight change greater than 5% during the previous 3 months. * Recent fracture within the previous 6 months. * Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation. * Chronic corticosteroid use. * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. * History of pancreatitis. * Smoking more than 7 cigarettes per day. * Previous malabsorptive or restrictive intestinal surgery or a malabsorptive syndrome. * Pregnancy or breastfeeding. * Recent history of neoplasia within the previous 5 years, as defined by the protocol. * Other active inflammatory conditions or neuromuscular disorders that could interfere with study outcomes or safety. * Serum 25-hydroxyvitamin D below 15 ng/mL. * Any medical, functional, laboratory, medication-related, or safety condition that the investigator determines makes study participation unsafe or prevents completion of essential procedures.
03Change log
Registry changes
No changes recorded since the trial was added.