Recruiting nowPhase 3Interventional
What this study 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
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age65 Years to Not listed
SexFemale
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Type 2
Full registry 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
Treatments and study arms
Semaglutide
Drug
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.
