Calcium-HMB + Vitamin D for Muscle Loss in Older Adults
(PRESERVE-HMB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Robb Flynn, PhD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 65 to 85 with type 2 diabetes who are starting semaglutide treatment. Participants should be generally healthy aside from their diabetes and related conditions like obesity or muscle loss.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive calcium-HMB plus vitamin D3 or placebo for approximately 6 months while semaglutide is managed as standard clinical care
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Mechanistic Substudy
Participants undergo additional assessments including D3-creatine dilution, stable isotope infusions, and muscle biopsies
What Are the Treatments Tested in This Trial?
Interventions
- Calcium beta-hydroxy-beta-methylbutyrate (Calcium-HMB) plus Vitamin D3
Trial Overview
The study tests whether taking calcium-HMB plus vitamin D3 daily, compared to a placebo, helps preserve muscle mass and function in older adults on semaglutide over about six months. It uses a randomized, double-blind design.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive active calcium-HMB plus vitamin D3 for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.
Participants receive matching placebo for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
American Diabetes Association
Collaborator
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