Vanderbilt Registers Trial of a Supplement to Preserve Muscle in Older Adults Starting Semaglutide, a Drug for Type 2 Diabetes and Weight Loss
Vanderbilt Registers Trial of a Supplement to Preserve Muscle in Older Adults Starting Semaglutide, a Drug for Type 2 Diabetes and Weight Loss
On August 12, ClinicalTrials.gov posted a record for a phase 2 trial at Vanderbilt University Medical Center. The trial will randomly assign 90 people aged 65–85 with type 2 diabetes who are starting semaglutide to receive either calcium HMB, a compound the body produces from leucine, with vitamin D3 or a placebo for six months.
Weight loss can include a reduction in lean tissue, including skeletal muscle. Older adults need muscle to maintain strength, walk, and live independently. In this trial, the participants’ treating physicians will prescribe and manage semaglutide therapy, while the research team will compare the supplement with placebo during the first six months of treatment.
A trial of TJ0113 is already recruiting people with diagnosed sarcopenia, the age-related loss of muscle mass, strength, and mobility. Its primary outcome will be 400-meter walking speed. The Vanderbilt trial will study people aged 65–85 with type 2 diabetes who are starting semaglutide.
Participants will be assigned in a 1:1 ratio, with allocation accounting for sex. One group will receive HMB with vitamin D3, while the other will receive a visually matched placebo. Participants, physicians, researchers, and outcome assessors will remain unaware of the assignments. Semaglutide will be managed as usual medical care in both groups, allowing the researchers to compare the supplement over the same treatment period.
The primary outcome will be the change in lean mass in the arms and legs over six months. Researchers will assess it using DXA, an X-ray scan that measures body composition. They will also measure handgrip and leg strength, distance covered during a six-minute walk, gait, and daily activity. Quantitative CT will show muscle volume and composition. Together, these measurements will relate changes in body composition to changes in strength and movement.
Up to 36 participants may join a separate part of the trial. A labeled creatine method will estimate the amount of contractile muscle tissue, while labeled amino acids and a thigh muscle biopsy will provide data on muscle protein synthesis and breakdown.
The combination of HMB and vitamin D3 has already been tested in older adults in a randomized trial. Vanderbilt will now test it in people who are just starting semaglutide. According to the study plan, data for the primary comparison will be collected by November 30, 2029.