Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes (NCT07428746) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
United States20 participantsStarted 2026-04
Plain-language 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
Who can participate
Age range
65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 between 7-10% 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, hy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.