Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
NCT07428746 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-24
Summary
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
Conditions
- Diabetes Mellitus, Type 2
Interventions
- 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.
Sponsors & Collaborators
-
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
collaborator NIH -
Emory University
lead OTHER
Principal Investigators
-
Thaer Idrees, MD, FSSCI · Emory University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2028-11-30
- Completion
- 2028-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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