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RECRUITING

NCT06497595

Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide

Sponsor: Sheba Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-11

Completion Date

2027-11-30

Last Updated

2026-07-21

Healthy Volunteers

Conditions

Type 2 Diabetes Mellitus in Obese

Interventions

BEHAVIORAL

Wegovy (2.4 Mg Dose) + exercise & nutrition

Participants will follow a 26-week, tri-weekly exercise program. One supervised 45-minute session will be conducted weekly via Zoom and recorded, with participants requested to repeat it twice independently on non-consecutive days. The program will include progressive resistance exercises alongside aerobic, balance, and flexibility training. Exercise intensity will be monitored using the Borg RPE scale, progressing gradually to a "somewhat hard" effort level (RPE 13-14). Weekly follow-up calls will track adherence and progress. The nutritional program will include individualized counseling, focusing on protein intake for sarcopenia prevention and personalized dietary adjustments based on health conditions and activity levels. Dietary intake will be monitored through food diaries and an adapted Food Frequency Questionnaire (FFQ). Weight will be tracked through self-reported measurements and on-site visits throughout the study.

OTHER

Wegovy (2.4 Mg Dose) + usual care

Participants allocated to the CG will receive general recommendations for PA according to the medical guidelines for PA for T2D. Guidelines recommend 150 minutes of moderate to vigorous-intensity aerobic activity per week, with no more than 2 consecutive days without activity, or engage in 75 minutes/week of vigorous-intensity or interval training. Incorporate 2-3 sessions/week of resistance exercise, decrease sedentary behavior and add flexibility and balance training 2-3 times/week. PA habits will be collected through a questionnaire during the first and final visit. Nutritional guidance will focus on adequate protein intake and reduced carbohydrate consumption, emphasizing fiber-rich, minimally processed sources. Dietary intake will be evaluated through an FFQ and 3-day food diaries at baseline and study completion.

Inclusion Criteria: 1. Patients 65 years and above. 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.

Locations (2)

Hadassah Medical Center

Jerusalem, Israel, Israel

Sheba medical center

Ramat Gan, Israel, Israel