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Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide
Exercise and Nutritional Intervention to Reduce the Risk of Sarcopenia in Older Adults With Type 2 Diabetes and Obesity Treated With Semaglutide: A Randomized Controlled Trial
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
60
estimated
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥27•Age 65-75
Primary endpoint
•Thigh muscle volume (TMV)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Patients 65-75 years old.
2. Patients who were previously diagnosed with type 2 diabetes.
3. Overweight / obesity (body mass index, BMI ≥ 27 kg/m2).
Exclusion criteria
1. Patients with significant hearing or visual disability.
2. Patients with Estimated Glomerular Filtration Rate (eGFR)<30 ml/min/1.73 m2.
3. Patients who are in active nutritional therapy.
4. Patients who changed their diet recently (< 1 month) and/or in a weight-loss program with >5% weight loss or used anti-obesity drugs in the last 3 months.
5. Patients who reported a weight loss of >5kg within 90 days of screening
6. Patients who were on Glucagon-like peptide-1 receptor agonists (GLP-1-RA) treatment during the last 3 months.
7. Patients with musculoskeletal disorders, which, by the judgment of the investigators, would limit their ability to perform the exercise training.
8. Patients with neurological diseases, which by the judgment of the investigators, would affect their ability to participate in the trial.
9. Patients with a history of amputation that impairs their ability to participate in the exercise program.
10. Patients with disabilities, which, by the judgment of the investigators, would affect their ability to participate in the trial.
11. Patients who use a walking aid.
12. Patients who are currently using systemic steroids.
13. Patients with active oncological diseases, excluding non-melanoma skin cancer.
14. Patients with diagnosed dementia or cognitive impairment that, in the view of the researchers, may impair their ability to sign a consent form or participate in the trial.
15. Patients who were hospitalized in the past month.
16. Patients who exercise regularly and in the eyes of the examiner will not benefit from the intervention program.
17. Anyone who is not suitable to participate in the study, according to the researcher's discretion.
18. Any contraindication to Magnetic resonance imaging (MRI) (e.g., MRI non-compatible cardiac implantable electronic device, metallic foreign bodies, implantable neurostimulation system, cochlear implants/ear implant, non-removable drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips which), or inability to perform an MRI scanner (e.g., claustrophobia).
19. Patients who do not fit within the measurement field of view of the Dual-energy X-ray absorptiometry (DXA) scanner in a supine position with the arms next to the body.
Endpoints (13)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
6 endpointsThigh muscle volume (TMV)
Time frame:26 weeks
change from baseline, improvement
Thigh muscle volume (TMV)
Time frame:26 weeks
descriptive
Fat distribution
Time frame:26 weeks
Total fat mass
change from baseline, improvement
Total lean mass
Time frame:26 weeks
Lean mass
change from baseline, improvement
Appendicular lean mass
Time frame:26 weeks
Lean mass
change from baseline, improvement
Muscle quality (muscle fat infiltration)
Time frame:26 weeks
change from baseline, improvement
Heart failure
1 endpoint6-minute walk test (6MWT) score
Time frame:26 weeks
6-minute walk distance
change from baseline, improvement
Other clinical outcomes
6 endpointsSit to stand test (STS) score
Time frame:26 weeks
change from baseline, improvement
Hand grip strength test score
Time frame:26 weeks
change from baseline, improvement
Timed up and go (TUG) test score
Time frame:26 weeks
change from baseline, improvement
10-meter walk test (10MWT) score
Time frame:26 weeks
change from baseline, improvement
Short physical performance battery (SPPB) test score
Time frame:26 weeks
change from baseline, improvement
Fried Frailty scale
Time frame:26 weeks
categorical status, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.