Clinical trial
Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide
Recruiting now · Not applicable · 1 countries · Registry ID NCT06497595
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
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.
Primary outcomes
Change in TMV from baseline to week 26
Study locations
2 locations were listed when this page was built. The first 40 are shown.