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Phase 3Recruiting

Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes

Sponsored by Emory University

About this study

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: * Receive GLP-1 RA therapy as part of their routine clinical care * Complete muscle strength assessments (hand grip strength, Timed Up and Go test) * Provide blood samples for bone turnover markers * Undergo bone mineral density testing

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 mana…

Where this study is enrolling

Who can participate

Inclusion criteria

  • ✓Postmenopausal women aged 65 years or older
  • ✓Has type 2 diabetes
  • ✓Body Mass Index (BMI) ≥27 kg/m² to max 40kg/m2 (inclusive)
  • ✓Hemoglobin A1c \>7% within 3 months of the first visit.
  • ✓Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.
  • ✓No osteoporosis confirmed on DEXA scan within 12 months
  • ✓Able to provide informed consent and participate in all study assessments

Exclusion criteria

  • ✕Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D
  • ✕eGFR \<30 ml/min in the last 3 months
  • ✕Patients with a history of treatment with anti-osteoporosis agents
  • ✕Documented primary or secondary osteoporosis on a DEXA scan within the last 12 months, or are on osteoporosis therapies
  • ✕Documented presence of prosthesis or devices in the spine or hip
  • ✕Previous fragility fracture
  • ✕Males
  • ✕Moderate to severe gastroesophageal reflux disease based on patient history.
  • ✕Inability to comply with the treatment protocol or to understand the consent form.
  • ✕Aspartate aminotransferase (AST) \> 3 times normal or alanine aminotransferase (ALT) \> 3 times the normal
  • ✕Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.
  • ✕Personal or family history of medullary thyroid carcinoma.
  • ✕Personal or family history of multiple endocrine neoplasia type 2 syndrome.
  • ✕Personal history of gastroparesis, celiac disease, hypogonadism, severe COPD, hypopituitarism, or Cushing's disease
  • ✕Personal history of severe diabetic retinopathy.
  • ✕Known serious hypersensitivity, including anaphylaxis and angioedema, to semaglutide or any of its excipients.
  • ✕Any of the following drugs or treatments were used within 6 months before screening: treated with GLP-1RA, GIP analogues, pioglitazones
  • ✕Concomitant treatment with GLP-1 receptor agonist therapy
  • ✕Long-term intravenous, oral, and intra-articular administration of high-dose corticosteroids within 2 months before screening (more than 7 days in a row)
  • ✕Use of weight control drugs or surgery that can lead to weight changes during the last 6 months before screening, or are currently in the weight loss plan and are not in the maintenance stage
  • ✕Incarcerated individuals

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Trial data sourced from ClinicalTrials.gov.