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.
Patients 65 years and above.
Patients who were previously diagnosed with type 2 diabetes.
Overweight / obesity (body mass index, BMI ≥ 27 kg/m2).
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.
Parallel
Wegovy (2.4 Mg Dose) + exercise & nutrition
BehavioralParticipants 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
Other interventionParticipants 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.
Thigh muscle volume (TMV)
Change in TMV from baseline to week 26
Thigh muscle volume (TMV)
TMV value in week 26
Sit to stand test (STS) score
Absolute and relative change in Sit to stanf test score from baseline to week 26. The number of times the participant stands up and sits down from a chair within 30 seconds is measured. The test results are compared to norms according to the participant's age and gender to assess lower limb strength. The higher the number of repetitions, the better the lower limb strength.
Hand grip strength test score
Absolute and relative change in hand grip measurement from baseline to week 26. The subject is instructed to squeeze the hand dynamometer with maximum isometric effort, which is maintained for about 5 seconds. The test results are compared to norms according to the participant's age and gender to assess upper limb strength. A score \< 27 kg for men and \< 16 kg for women is considered a risk for sarcopenia.
Timed up and go (TUG) test score
Absolute and relative change in Timed up and go test score from baseline to week 26. The time it takes the participant to rise from a chair, walk 3 meters and return to a seated position is measured. The test results are compared to norms according to the participant's age and gender to assess dynamic balance and fall risk. The shorter the time taken to complete the task, the higher the ability, with a result over 14 seconds indicating an increased risk of falls.
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Sheba Medical Center
Lead sponsor
Hadassah Medical Organization
Collaborator
