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

Not Yet RecruitingPhase 2

Sponsor: Vanderbilt University Medical Center

Conditions: Type 2 Diabetes Mellitus (T2DM), Sarcopenia, Obesity, Muscle Loss, Older Adults

Interventions: Calcium-HMB Plus Vitamin D3, Matching placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 65 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Nashville, Tennessee, United States