Diabetes Mellitus, Type 2Phase 3GLOWNCT07428746
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jaafer Zaino contact
United States1 site, 1 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Thaer Idrees, MD, FSSCI, 404-251-5357, thaer.idrees@emory.edu
Thayer Idrees, MD
About this study
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
Read the detailed description
Older females with type 2 diabetes experience a disproportionately high burden of osteosarcopenia, a condition defined by the coexistence of low muscle mass, reduced muscle strength, and decreased bone mineral density. Osteosarcopenia is associated with increased risks of falls, fractures, functional decline, hospitalization, and loss of independence. Diabetes contributes to these risks through multiple mechanisms, including impaired bone microarchitecture, reduced muscle quality, neuropathy-related balance disturbances, and chronic inflammation. These effects are amplified in older women, who already experience age-related declines in muscle and bone health following menopause.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including semaglutide, are widely used for glycemic management and weight reduction in type 2 diabetes. While these medications provide substantial metabolic benefits, clinical studies have reported that weight loss associated with GLP-1 RA therapy may include reductions in lean body mass. The implications of these changes for muscle strength, bone turnover, and bone mineral density remain unclear, particularly in older females with type 2 diabetes who may be more vulnerable to muscle and bone loss. Existing data on GLP-1 RAs and fracture risk are limited and inconsistent, and most prior studies have evaluated older, less potent agents with minimal weight-loss effects.
This prospective observational study is designed to characterize changes in muscle and bone health during 6 months of GLP-1 RA therapy in older females with type 2 diabetes who are receiving treatment as part of routine clinical care. The study will enroll 20 women over the age of 65. Participants will undergo standardized assessments of muscle strength, bone turnover markers, and bone mineral density at baseline and follow-up. Muscle strength will be evaluated using validated functional measures, and bone health will be assessed through laboratory markers of bone remodeling and imaging-based measures of bone density.
The study does not alter clinical treatment decisions; GLP-1 RA therapy is prescribed independently by participants' healthcare providers based on FDA-approved indications. Study procedures focus on evaluating physiological changes associated with treatment in a population at elevated risk for osteosarcopenia. Data collected will help clarify whether GLP-1 RA therapy influences muscle strength, bone turnover, or bone mineral density in older females with type 2 diabetes. Findings may inform future strategies to support musculoskeletal health in this growing and medically vulnerable population.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide
- Keywords
- GLP-1 Receptor analogs, Semaglutide, DEXA, Osteosarcopenia, Bone Mineral Density, Bone turnover markers
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called GLP 1 RA
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.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetics on Semaglutide | Experimental | Participants will receive a GLP-1 receptor agonist (GLP-1 RA) prescribed as part of their routine clinical care. Dosing will follow standard clinical practice and will be titrated to each participant's maximum tolerated dose. The study will observe metabolic, musculoskeletal, and functional changes associated with ongoing GLP-1 RA therapy over a 6-month period. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in handgrip strength
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
Measured: Baseline, week4, week 8, week12, week 26.
Secondary outcomes (10)
Change in bone turnover markers
Bone turnover markers (BTMs) reflect the rate of bone remodeling, including both bone formation and bone resorption processes. These laboratory biomarkers provide insight into dynamic skeletal changes that may occur during GLP-1 receptor agonist therapy.
BTMs may include:
- Bone formation markers (e.g., P1NP)
- Bone resorption markers (e.g., CTX) Results will be reported in standard laboratory units (e.g., ng/mL, µg/L), depending on the specific assay.
Higher formation markers indicate increased bone formation; higher resorption markers indicate increased bone breakdown
Measured: Baseline, 3 month, 6 months
Change in timed up-and-go (TUG)
The Timed Up and Go (TUG) test assesses functional mobility by measuring the time required for a participant to rise from a standard chair, walk to a marked 10-foot line, turn around, return to the chair, and sit down.
Time is recorded in seconds (s).
- Shorter times indicate better functional mobility.
- Longer times may reflect impairments in balance, gait speed, or lower-extremity strength.
Measured: Baseline, week4, week 8, week12, week 26.
Change in HbA1c
Collected via venous blood sample and analyzed using standardized laboratory assays.
HbA1c will be reported as a percentage (%). Reductions in HbA1c and fasting glucose reflect improved insulin sensitivity and glycemic regulation.
Measured: Baseline, 3 month, 6 months
Change in fasting glucose
Measured after an overnight fast of at least 8 hours. Fasting glucose will be reported in mg/dL. Reductions in fasting glucose reflect improved insulin sensitivity and glycemic regulation
Measured: Baseline, 6 months
Change in weight
Measured using a calibrated digital scale with participants wearing light clothing and no shoes.
Body weight will be reported in kilograms (kg).
Weight change (kg) will be calculated as the difference between baseline and follow-up measurements
Measured: Baseline, week4, week 8, week12, week 26.
Change in FRAX score
Fracture risk will be evaluated using the FRAX algorithm, which integrates bone mineral density (BMD) at the femoral neck with validated clinical risk factors to estimate the 10-year probability of major osteoporotic fracture and hip fracture.
FRAX results are expressed as percent probabilities (%). Lower percentages indicate reduced fracture risk.
Measured: Baseline, 6 months
Change in lipid profile
Serial lipid measurements will be collected to evaluate cardiovascular risk modification during GLP-1 receptor agonist therapy.
LDL-C, HDL-C, triglycerides, and total cholesterol will be reported in mg/dL.
- Change in each lipid parameter will be calculated as the difference between baseline and 6-month values.
- Lower LDL-C and triglycerides, along with higher HDL-C, indicate improved cardiovascular risk profiles.
Measured: Baseline, 3 months, 6 months
Changes in exercise frequency
The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire is a validated self-report tool designed to assess weekly frequency and duration of lifestyle physical activities commonly performed by older adults. It captures a broad range of activities across light, moderate, and vigorous intensities, providing a comprehensive estimate of habitual physical activity.
Responses are used to calculate the total weekly frequency of various activity categories.
Weekly frequency of each activity (number of sessions per week)
Measured: Baseline, 6 months
Changes in exercise duration
The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire is a validated self-report tool designed to assess weekly frequency and duration of lifestyle physical activities commonly performed by older adults. It captures a broad range of activities across light, moderate, and vigorous intensities, providing a comprehensive estimate of habitual physical activity.
Responses are used to calculate the total weekly duration of various activity categories.
Higher values indicate greater physical activity engagement.
Measured: Baseline, 6 months
Change in frailty assessment
Frailty will be assessed using a questionnaire based on the Fried phenotype, evaluating five components: unintentional weight loss, exhaustion, low physical activity, slowness, and weakness. A structured data capture form modeled on the validated assessment will be used.
Assessment Procedure \& Scoring:
- Completed at baseline and 6 months.
- Each criterion is scored as present or absent (0-5 total).
- 0: Non-frail
- 1-2: Pre-frail
- ≥3: Frail
Interpretation:
Higher scores indicate greater frailty; changes over time reflect shifts in physiologic vulnerability.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start7 May 2026
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Thaer Idrees, Emory University
- Investigators
- Thaer Idrees, MD, FSSCI, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428746
- Sponsor's protocol ID
- 2025P013673
- Other IDs
- K12AR084234
- Acronym
- GLOW
- Status last verified
- Jul 2026
- First submitted
- 17 Feb 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
- ClinicalTrials.gov ID
- NCT07428746
- Acronym / sponsor ID
- GLOW / 2025P013673
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- GLP-1 Receptor analogs, Semaglutide, DEXA, Osteosarcopenia, Bone Mineral Density, Bone turnover markers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 7 May 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Older females with type 2 diabetes experience a disproportionately high burden of osteosarcopenia, a condition defined by the coexistence of low muscle mass, reduced muscle strength, and decreased bone mineral density. Osteosarcopenia is associated with increased risks of falls, fractures, functional decline, hospitalization, and loss of independence. Diabetes contributes to these risks through multiple mechanisms, including impaired bone microarchitecture, reduced muscle quality, neuropathy-related balance disturbances, and chronic inflammation. These effects are amplified in older women, who already experience age-related declines in muscle and bone health following menopause.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including semaglutide, are widely used for glycemic management and weight reduction in type 2 diabetes. While these medications provide substantial metabolic benefits, clinical studies have reported that weight loss associated with GLP-1 RA therapy may include reductions in lean body mass. The implications of these changes for muscle strength, bone turnover, and bone mineral density remain unclear, particularly in older females with type 2 diabetes who may be more vulnerable to muscle and bone loss. Existing data on GLP-1 RAs and fracture risk are limited and inconsistent, and most prior studies have evaluated older, less potent agents with minimal weight-loss effects.
This prospective observational study is designed to characterize changes in muscle and bone health during 6 months of GLP-1 RA therapy in older females with type 2 diabetes who are receiving treatment as part of routine clinical care. The study will enroll 20 women over the age of 65. Participants will undergo standardized assessments of muscle strength, bone turnover markers, and bone mineral density at baseline and follow-up. Muscle strength will be evaluated using validated functional measures, and bone health will be assessed through laboratory markers of bone remodeling and imaging-based measures of bone density.
The study does not alter clinical treatment decisions; GLP-1 RA therapy is prescribed independently by participants' healthcare providers based on FDA-approved indications. Study procedures focus on evaluating physiological changes associated with treatment in a population at elevated risk for osteosarcopenia. Data collected will help clarify whether GLP-1 RA therapy influences muscle strength, bone turnover, or bone mineral density in older females with type 2 diabetes. Findings may inform future strategies to support musculoskeletal health in this growing and medically vulnerable population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetics on Semaglutide | Experimental | Drug: SemaglutideParticipants will receive a GLP-1 receptor agonist (GLP-1 RA) prescribed as part of their routine clinical care. Dosing will follow standard clinical practice and will be titrated to each participant's maximum tolerated dose. The study will observe metabolic, musculoskeletal, and functional changes associated with ongoing GLP-1 RA therapy over a 6-month period. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: GLP 1 RASemaglutide 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. | Drug | Type 2 Diabetics on Semaglutide |
Primary outcome
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
10 secondary outcomes
Change in bone turnover markers
Time frame: Baseline, 3 month, 6 months
Change in timed up-and-go (TUG)
Time frame: Baseline, week4, week 8, week12, week 26.
Change in HbA1c
Time frame: Baseline, 3 month, 6 months
Change in fasting glucose
Time frame: Baseline, 6 months
Change in weight
Time frame: Baseline, week4, week 8, week12, week 26.
Change in FRAX score
Time frame: Baseline, 6 months
Change in lipid profile
Time frame: Baseline, 3 months, 6 months
Changes in exercise frequency
Time frame: Baseline, 6 months
Changes in exercise duration
Time frame: Baseline, 6 months
Change in frailty assessment
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaafer Zaino contact
Thaer Idrees, MD, FSSCI principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thaer Idrees, MD, FSSCI (404-251-5357, thaer.idrees@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in handgrip strength (time frame: Baseline, week4, week 8, week12, week 26.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.