Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
Recruiting · NCT07428746 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
65 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Grady Memorial Hospital - Atlanta, Georgia, United States