Clinical Trial

HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide

Study acronym: PRESERVE-HMB
Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07760948
Lead Sponsor Vanderbilt University Medical Center
Collaborators: American Diabetes Association
Conditions Type 2 Diabetes Mellitus (T2DM), Sarcopenia, Obesity, Muscle Loss, Older Adults
Enrollment 90 participants
Start Date 2026-12-01
Primary Completion 2029-11-30 (estimated)
Study Completion 2030-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-12