Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide
- Conditions
- Type 2 Diabetes Mellitus in Obese
- Registration Number
- NCT06497595
- Lead Sponsor
- Sheba Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria:<br><br> 1. Patients 65-75 years old.<br><br> 2. Patients who were previously diagnosed with type 2 diabetes.<br><br> 3. Overweight / obesity (body mass index, BMI = 27 kg/m2).<br><br>Exclusion Criteria:<br><br> 1. Patients with significant hearing or visual disability.<br><br> 2. Patients with Estimated Glomerular Filtration Rate (eGFR)<30 ml/min/1.73 m2.<br><br> 3. Patients who are in active nutritional therapy.<br><br> 4. Patients who changed their diet recently (< 1 month) and/or in a weight-loss program<br> with >5% weight loss or used anti-obesity drugs in the last 3 months.<br><br> 5. Patients who reported a weight loss of >5kg within 90 days of screening<br><br> 6. Patients who were on Glucagon-like peptide-1 receptor agonists (GLP-1-RA) treatment<br> during the last 3 months.<br><br> 7. Patients with musculoskeletal disorders, which, by the judgment of the<br> investigators, would limit their ability to perform the exercise training.<br><br> 8. Patients with neurological diseases, which by the judgment of the investigators,<br> would affect their ability to participate in the trial.<br><br> 9. Patients with a history of amputation that impairs their ability to participate in<br> the exercise program.<br><br> 10. Patients with disabilities, which, by the judgment of the investigators, would<br> affect their ability to participate in the trial.<br><br> 11. Patients who use a walking aid.<br><br> 12. Patients who are currently using systemic steroids.<br><br> 13. Patients with active oncological diseases, excluding non-melanoma skin cancer.<br><br> 14. Patients with diagnosed dementia or cognitive impairment that, in the view of the<br> researchers, may impair their ability to sign a consent form or participate in the<br> trial.<br><br> 15. Patients who were hospitalized in the past month.<br><br> 16. Patients who exercise regularly and in the eyes of the examiner will not benefit<br> from the intervention program.<br><br> 17. Anyone who is not suitable to participate in the study, according to the<br> researcher's discretion.<br><br> 18. Any contraindication to Magnetic resonance imaging (MRI) (e.g., MRI non-compatible<br> cardiac implantable electronic device, metallic foreign bodies, implantable<br> neurostimulation system, cochlear implants/ear implant, non-removable drug infusion<br> pumps, catheters with metallic components, cerebral artery aneurysm clips which), or<br> inability to perform an MRI scanner (e.g., claustrophobia).<br><br> 19. Patients who do not fit within the measurement field of view of the Dual-energy<br> X-ray absorptiometry (DXA) scanner in a supine position with the arms next to the<br> body.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Thigh muscle volume (TMV)
- Secondary Outcome Measures
Name Time Method Thigh muscle volume (TMV);Sit to stand test (STS) score;Hand grip strength test score;Timed up and go (TUG) test score;6-minute walk test (6MWT) score;10-meter walk test (10MWT) score;Short physical performance battery (SPPB) test score;Fried Frailty scale;Fat distribution;Total lean mass;Appendicular lean mass;Muscle quality (muscle fat infiltration)