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 65-75) 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 exercise and food consumption. Participants in the intervention group will participate in an online exercise program and will receive personal nutritional counseling.
Patients 65-75 years old.
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 participate in a 26-week, tri-weekly, exercise program. One 45-minute exercise session will be provided via a virtual meeting platform each week and recorded. The participants will be asked to independently repeat each recorded session twice on separate, non-consecutive days of the week without supervision. The program will focus on progressive resistance exercises using body weight, a resistance band and various household items. A weekly follow-up call will be conducted to gather feedback and monitor adherence along with a personal exercise diary that each participant will fill out and bring to each on-site visit. Each exercise session will be performed in small groups and will be administered by a fitness specialist. In addition, participants will receive personal individualized nutritional counseling which will be administered every 2-4 weeks online via ZOOM. A certified dietitian will conduct all diet sessions.
Wegovy (2.4 Mg Dose) + usual care
Other interventionParticipants will receive dietary guidance as customary among patients with type 2 diabetes (T2D) and obesity monitored in a diabetes clinic. Additionally, general recommendations for physical activity (PA) according to the medical guidelines for PA for T2D will be given. Guidelines recommend 150 minutes or more of moderate to vigorous-intensity aerobic activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity, or engage in 75 minutes/week of vigorous-intensity or interval training (for more physically fit individuals). Incorporate 2-3 sessions/week of resistance exercise on nonconsecutive days, decrease sedentary behavior and add flexibility and balance training 2-3 times/week. Participants in the GHRG will be requested to fill out an exercise diary (report on unsupervised training days) and a 2-day food diary for periodic monitoring which they will bring with them to each on-site visit.
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
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