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

RecruitingPhase 3

Sponsor: Emory University

Conditions: Diabetes Mellitus, Type 2

Interventions: Semaglutide

Countries: United States

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

Eligibility overview

Sex: FEMALE

Age: 65 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Atlanta, Georgia, United States