GLP-1RA therapy for osteosarcopenia in older women with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, interventional study will administer semaglutide to older women with type 2 diabetes and assess changes in muscle strength, bone turnover markers, and bone mineral density over six months. Participants will undergo hand grip strength tests, the Timed Up and Go test, blood draws, and DEXA scans as part of routine clinical care. The study aims to clarify whether GLP-1 RA therapy can benefit musculoskeletal health in this high-risk population, addressing gaps in data about lean mass and fracture risk.

Why it matters

Who can join: the full rules

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's running

• Grady Memorial Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Thaer Idrees, MD, FSSCI — Emory University
• Study coordinator: Thaer Idrees, MD, FSSCI
• Email: thaer.idrees@emory.edu
• Phone: 404-251-5357

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.