BACKGROUND Older adults with type 2 diabetes mellitus (T2DM) or prediabetes are at increased risk of adverse changes in body composition, physical function, and concentrations of biomarkers of aging compared with those with normal glucose tolerance. Semaglutide is a glucagon-like peptide 1 receptor agonist that has been approved for T2DM and chronic weight management. Although semaglutide is effective for weight loss and T2DM management, its effects on lean body mass, physical function, and biomarkers of aging are understudied in older adults. OBJECTIVE This randomized, open-label, controlled trial aims to compare the effects of semaglutide in addition to lifestyle counseling vs. lifestyle counseling alone on body composition, physical function, and biomarkers of aging in 20 older adults (n=10 per group) with elevated BMI (27-40 kg/m2) and glucose intolerance (HgbA1c 5.7-7.5%). METHODS Older adults (≥65 y) with prediabetes or well-controlled T2DM will be recruited, stratified by gender, and randomized to one of the two groups (semaglutide plus lifestyle counseling vs lifestyle counseling alone) and followed for five months. Those in the semaglutide group will be titrated to 1 mg weekly, as tolerated, for 12 weeks. Lifestyle counseling will be given by Registered Dietitians and is based on the Diabetes Prevention Program Lifestyle Change Program. Our primary outcomes include changes in lean mass, physical function, and biomarkers of aging. Body composition will be measured by dual-energy X-ray absorptiometry and include total fat mass and lean mass. Physical function will be measured by 6-minute walk distance, grip strength, and short physical performance battery. Biomarkers of aging will be measured in blood, skeletal muscle, and abdominal adipose tissue to include C-reactive protein, interleukin-6, tumor necrosis factors α, and β galactosidase staining. RESULTS The study was funded in December 2021 with a projected data collection period from April 2023 through Summer 2024. CONCLUSIONS Despite the elevated risk of adverse changes in body composition, physical function, and biomarkers of aging among older adults with glucose intolerance and elevated adiposity, the benefits, and risks of commonly prescribed anti-hyperglycemic or weight loss medications such as semaglutide are understudied. This study aims to fill this knowledge gap to inform clinicians about non-glycemic effects of semaglutide and optimize management in this population.
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