NCT07428746 · Emory University
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
(GLOW)
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.
View original scientific description
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.
Interventions
DRUG
Semaglutide
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.
Primary outcome measures
Change in handgrip strength
Time frame: Baseline, week4, week 8, week12, week 26.
Handgrip strength is a validated indicator of overall muscle strength and a core diagnostic component of sarcopenia. HGS will be assessed using a calibrated hydraulic hand dynamometer. Output is recorded in kilograms (kg) of force. Higher values indicate greater muscle strength
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Atlanta, Georgia
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 3, 2026 · Source of record for eligibility and locations