HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide (NCT07760948) | Clinical Trial Compass
Not Yet RecruitingPhase 2
HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
United States90 participantsStarted 2026-12-01
Plain-language summary
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.
Who can participate
Age range
65 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ac…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.