A Phase 3 interventional study of Semaglutide in Diabetes Mellitus, Type 2, sponsored by Emory University. Recruiting at 1 site in United States. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Emory University · Phase 3, Interventional, and Treatment
The goal of this study is to learn how GLP-1 receptor agonist therapy affects muscle and bone health in older females over age 65 with type 2 diabetes.
The main question it aims to answer is whether or not 6 months of GLP-1 RA therapy affects muscle strength.
Participants will:
Older females with type 2 diabetes experience a disproportionately high burden of osteosarcopenia, a condition defined by the coexistence of low muscle mass, reduced muscle strength, and decreased bone mineral density. Osteosarcopenia is associated with increased risks of falls, fractures, functional decline, hospitalization, and loss of independence. Diabetes contributes to these risks through multiple mechanisms, including impaired bone microarchitecture, reduced muscle quality, neuropathy-related balance disturbances, and chronic inflammation. These effects are amplified in older women, who already experience age-related declines in muscle and bone health following menopause.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including semaglutide, are widely used for glycemic management and weight reduction in type 2 diabetes. While these medications provide substantial metabolic benefits, clinical studies have reported that weight loss associated with GLP-1 RA therapy may include reductions in lean body mass. The implications of these changes for muscle strength, bone turnover, and bone mineral density remain unclear, particularly in older females with type 2 diabetes who may be more vulnerable to muscle and bone loss. Existing data on GLP-1 RAs and fracture risk are limited and inconsistent, and most prior studies have evaluated older, less potent agents with minimal weight-loss effects.
This prospective observational study is designed to characterize changes in muscle and bone health during 6 months of GLP-1 RA therapy in older females with type 2 diabetes who are receiving treatment as part of routine clinical care. The study will enroll 20 women over the age of 65. Participants will undergo standardized assessments of muscle strength, bone turnover markers, and bone mineral density at baseline and follow-up. Muscle strength will be evaluated using validated functional measures, and bone health will be assessed through laboratory markers of bone remodeling and imaging-based measures of bone density.
The study does not alter clinical treatment decisions; GLP-1 RA therapy is prescribed independently by participants' healthcare providers based on FDA-approved indications. Study procedures focus on evaluating physiological changes associated with treatment in a population at elevated risk for osteosarcopenia. Data collected will help clarify whether GLP-1 RA therapy influences muscle strength, bone turnover, or bone mineral density in older females with type 2 diabetes. Findings may inform future strategies to support musculoskeletal health in this growing and medically vulnerable population.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Exclusion Criteria:
Participants will receive a GLP-1 receptor agonist (GLP-1 RA) prescribed as part of their routine clinical care. Dosing will follow standard clinical practice and will be titrated to each participant's maximum tolerated dose. The study will observe metabolic, musculoskeletal, and functional changes associated with ongoing GLP-1 RA therapy over a 6-month period.
Drug: Semaglutide
Semaglutide is an FDA-approved drug for the treatment of T2D at the following doses (0.25, 0.5, 1, and 2 mg) that is self-administered weekly using an autoinjector pen. The drug dosage will gradually increase every 4 weeks if tolerated to reach maintenance doses of 2 mg for semaglutide until the end of the study (6 months). If a participant cannot tolerate a dose, the highest tolerable dose will be administered, with continued efforts to increase the dose over time, gradually.
Also known as: GLP 1 RA
Change in handgrip strength
Handgrip strength is a validated indicator of overall muscle strength and a core diagnostic component of sarcopenia. HGS will be assessed using a calibrated hydraulic hand dynamometer. Output is recorded in kilograms (kg) of force. Higher values indicate greater muscle strength
Time frame: Baseline, week4, week 8, week12, week 26.
Change in bone turnover markers
Bone turnover markers (BTMs) reflect the rate of bone remodeling, including both bone formation and bone resorption processes. These laboratory biomarkers provide insight into dynamic skeletal changes that may occur during GLP-1 receptor agonist therapy. BTMs may include: * Bone formation markers (e.g., P1NP) * Bone resorption markers (e.g., CTX) Results will be reported in standard laboratory units (e.g., ng/mL, µg/L), depending on the specific assay. Higher formation markers indicate increased bone formation; higher resorption markers indicate increased bone breakdown
Time frame: Baseline, 3 month, 6 months
Change in timed up-and-go (TUG)
The Timed Up and Go (TUG) test assesses functional mobility by measuring the time required for a participant to rise from a standard chair, walk to a marked 10-foot line, turn around, return to the chair, and sit down. Time is recorded in seconds (s). * Shorter times indicate better functional mobility. * Longer times may reflect impairments in balance, gait speed, or lower-extremity strength.
Time frame: Baseline, week4, week 8, week12, week 26.
Change in HbA1c
Collected via venous blood sample and analyzed using standardized laboratory assays. HbA1c will be reported as a percentage (%). Reductions in HbA1c and fasting glucose reflect improved insulin sensitivity and glycemic regulation.
Time frame: Baseline, 3 month, 6 months
Change in fasting glucose
Measured after an overnight fast of at least 8 hours. Fasting glucose will be reported in mg/dL. Reductions in fasting glucose reflect improved insulin sensitivity and glycemic regulation
Time frame: Baseline, 6 months
Change in weight
Measured using a calibrated digital scale with participants wearing light clothing and no shoes. Body weight will be reported in kilograms (kg). Weight change (kg) will be calculated as the difference between baseline and follow-up measurements
Time frame: Baseline, week4, week 8, week12, week 26.
Change in FRAX score
Fracture risk will be evaluated using the FRAX algorithm, which integrates bone mineral density (BMD) at the femoral neck with validated clinical risk factors to estimate the 10-year probability of major osteoporotic fracture and hip fracture. FRAX results are expressed as percent probabilities (%). Lower percentages indicate reduced fracture risk.
Time frame: Baseline, 6 months
Change in lipid profile
Serial lipid measurements will be collected to evaluate cardiovascular risk modification during GLP-1 receptor agonist therapy. LDL-C, HDL-C, triglycerides, and total cholesterol will be reported in mg/dL. * Change in each lipid parameter will be calculated as the difference between baseline and 6-month values. * Lower LDL-C and triglycerides, along with higher HDL-C, indicate improved cardiovascular risk profiles.
Time frame: Baseline, 3 months, 6 months
Changes in exercise frequency
The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire is a validated self-report tool designed to assess weekly frequency and duration of lifestyle physical activities commonly performed by older adults. It captures a broad range of activities across light, moderate, and vigorous intensities, providing a comprehensive estimate of habitual physical activity. Responses are used to calculate the total weekly frequency of various activity categories. Weekly frequency of each activity (number of sessions per week)
Time frame: Baseline, 6 months
Changes in exercise duration
The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire is a validated self-report tool designed to assess weekly frequency and duration of lifestyle physical activities commonly performed by older adults. It captures a broad range of activities across light, moderate, and vigorous intensities, providing a comprehensive estimate of habitual physical activity. Responses are used to calculate the total weekly duration of various activity categories. Higher values indicate greater physical activity engagement.
Time frame: Baseline, 6 months
Change in frailty assessment
Frailty will be assessed using a questionnaire based on the Fried phenotype, evaluating five components: unintentional weight loss, exhaustion, low physical activity, slowness, and weakness. A structured data capture form modeled on the validated assessment will be used. Assessment Procedure \& Scoring: * Completed at baseline and 6 months. * Each criterion is scored as present or absent (0-5 total). * 0: Non-frail * 1-2: Pre-frail * ≥3: Frail Interpretation: Higher scores indicate greater frailty; changes over time reflect shifts in physiologic vulnerability.
Time frame: Baseline, 6 months
Change in bone mineral density
Bone mineral density will be assessed using dual-energy X-ray absorptiometry (DEXA). Imaging will be performed at the femoral neck, total hip, and lumbar spine, which are standard anatomical sites for evaluating osteoporosis and fracture risk. BMD will be reported in grams per square centimeter (g/cm²). Z-scores reflect how a participant's bone density compares with expected values for individuals of the same demographic profile. Lower Z-scores may indicate reduced bone density and increased susceptibility to osteopenia or osteoporosis.
Time frame: Baseline, 6 months
Plan to share: Yes
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