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Not yet recruitingPhase NA

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

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 ≥27Age 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

NCT IDNCT06497595
Org study ID1072-24-SMC

Timeline

Milestones

Study first posted2024-07-12actual
Last update posted2024-08-22actual
Study start2024-08-30estimated
Primary completion2025-01-30estimated
Study completion2025-08-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age65 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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
Other clinical outcomes
6
Heart failure
1

Weight & body composition

6 endpoints
Primary/protocol endpoint

Thigh muscle volume (TMV)

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Thigh muscle volume (TMV)

Time frame:26 weeks

descriptive

Secondary/protocol endpoint

Fat distribution

Time frame:26 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Total lean mass

Time frame:26 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Appendicular lean mass

Time frame:26 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Muscle quality (muscle fat infiltration)

Time frame:26 weeks

change from baseline, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

6-minute walk test (6MWT) score

Time frame:26 weeks

6-minute walk distance

change from baseline, improvement

Other clinical outcomes

6 endpoints
Secondary/protocol endpoint

Sit to stand test (STS) score

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Hand grip strength test score

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Timed up and go (TUG) test score

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

10-meter walk test (10MWT) score

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Short physical performance battery (SPPB) test score

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Fried Frailty scale

Time frame:26 weeks

categorical status, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.