Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide
NCT Number: NCT06497595
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes Mellitus in Obese
Interventions: BEHAVIORAL: Wegovy (2.4 Mg Dose) + exercise & nutrition|OTHER: Wegovy (2.4 Mg Dose) + usual care
Sponsor: Sheba Medical Center
Collaborators: Hadassah Medical Organization
Sex: ALL
Age: OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-08-30
Locations: Hadassah Medical Center, Jerusalem, 5251108, Israel|Sheba medical center, Ramat-Gan, 52621, Israel

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 65-75) 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.

Primary Outcome Measures: Thigh muscle volume (TMV), Change in TMV from baseline to week 26, 26 weeks
Secondary Outcome Measures: Thigh muscle volume (TMV), TMV value in week 26, 26 weeks|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., 26 weeks|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., 26 weeks|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., 26 weeks|6-minute walk test (6MWT) score, Absolute and relative change in the 6-minute walk test score from baseline to week 26. The distance covered over 6 minutes is used as the outcome by which to compare changes in performance capacity. The test results are compared to norms according to the participant's age and gender to assess aerobic capacity and endurance. A longer distance covered indicates better aerobic capacity and physical performance., 26 weeks|10-meter walk test (10MWT) score, Absolute and relative change in the 10-meter walk test score from baseline to week 26. The time it takes the participant to walk at a comfortable pace for 10 meters is measured. A score ≤ 0.8 meter per second (m/s) indicates low physical function and risk for falls., 26 weeks|Short physical performance battery (SPPB) test score, Absolute and relative change in the SPPB test score from baseline to week 26. The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility. The total score ranges from 0-12, a high score indicates high functional capacity while a score below 8 indicates low functional capacity and raises the suspicion of sarcopenia., 26 weeks|Fried Frailty scale, Change in state of frailty from baseline to week 26. The fried frailty scale includes five components, unintentional weight loss (10 lbs. in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity. The presence of one or two deficits indicates pre-frailty, and a total of three or more deficits indicate frailty, while the absence of deficits indicates a robust state., 26 weeks|Fat distribution, Absolute and relative change in total fat mass from baseline to week 26, 26 weeks|Total lean mass, Absolute and relative change in total lean mass from baseline to week 26, 26 weeks|Appendicular lean mass, Absolute and relative change in appendicular lean mass from baseline to week 26, 26 weeks|Muscle quality (muscle fat infiltration), Absolute and relative change in muscle fat infiltration from baseline to week 26, 26 weeks