What this trial means for you
This study is opening soon at 1 US site. It's studying see the official record for type 2 diabetes mellitus (t2dm), sarcopenia, obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of usual clinical care. Participants will receive calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months. The primary outcome is change in appendicular lean mass measured by dual-energy X-ray absorptiometry from baseline to month 6. Secondary assessments include body composition, muscle strength, physical performance, gait, physical activity, resting metabolic rate, metabolic measures, and whole-body quantitative computed tomography. An optional mechanistic substudy of up to 36 participants will include D3-creatine dilution, nonradioactive stable isotope infusions, repeated blood sampling, a standardized meal, breath sampling, and vastus lateralis muscle biopsies at baseline and month 6.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
Tennessee
- Vanderbilt University Medical Center, Nashville
View the official record on ClinicalTrials.gov →
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