Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide
Recruiting now · Not applicable
Conditions studied: Type 2 Diabetes Mellitus in Obese
In brief
This study aims to test whether a multi-disciplinary intervention involving exercise and nutrition can slow down the decline in physical function, muscle strength and mass in older adults (aged 65 and above) with Type 2 diabetes (T2D) and obesity treated with Semaglutide. The main questions it aims to answer are: In older people with T2D and obesity, treated with Semaglutide, does a multi-disciplinary intervention of exercise and nutrition compared to standard health recommendations: 1. Reduce the rate of decline in muscle mass? 2. Reduce the rate of decline in muscle strength? 3. Reduce the rate of decline in physical function? Participants will: Administer Semaglutide once weekly for 6 months. Visit the clinic once every 8 weeks for checkups and tests. Keep a diary of their food consumption. Participants in the intervention group will participate in an online exercise program and will receive personal nutritional counseling.
Key facts
- Study ID
- NCT06497595
- Run by
- Sheba Medical Center
- People needed
- 60
- Starts
- 2025-05-11
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2026-07-21
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 65 years and above.
- Patients who were previously diagnosed with type 2 diabetes.
- Overweight / obesity (body mass index, BMI ≥ 27 kg/m2).
You may not qualify if…
- Patients with significant hearing or visual disability.
- Patients with Estimated Glomerular Filtration Rate (eGFR)<30 ml/min/1.73 m2.
- Patients who are in active nutritional therapy.
- 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.
- Patients who reported a weight loss of >5kg within 90 days of screening
- Patients who were on Glucagon-like peptide-1 receptor agonists (GLP-1-RA) treatment during the last 3 months.
- Patients with musculoskeletal disorders, which, by the judgment of the investigators, would limit their ability to perform the exercise training.
- Patients with neurological diseases, which by the judgment of the investigators, would affect their ability to participate in the trial.
- Patients with a history of amputation that impairs their ability to participate in the exercise program.
- Patients with disabilities, which, by the judgment of the investigators, would affect their ability to participate in the trial.
- Patients who use a walking aid.
- Patients who are currently using systemic steroids.
- Patients with active oncological diseases, excluding non-melanoma skin cancer.
- 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.
- Patients who were hospitalized in the past month.
- Patients who exercise regularly and in the eyes of the examiner will not benefit from the intervention program.
- Anyone who is not suitable to participate in the study, according to the researcher's discretion.
- 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).
- 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.
Where it is running
- Sheba medical center — Ramat Gan, Israel, Israel (enrolling)
- Hadassah Medical Center — Jerusalem, Israel, Israel
Full record on ClinicalTrials.gov
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