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

Study acronym: STAY-STRONG
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Primary completion date: Jan 30, 2025 to Sep 30, 2027
    • Start date changed from estimate of Aug 30, 2024 to May 11, 2025
    • Study completion date: Aug 30, 2025 to Nov 30, 2027
    • Study description expanded, about 291 words
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 1 word
  2. Interventions: Wegovy (2.4 Mg Dose) + exercise + nutrition (Drug), Wegovy (2.4 Mg Dose) + usual care (Drug) to Wegovy (2.4 Mg Dose) + exercise & nutrition (Behavioral), Wegovy (2.4 Mg Dose) + usual care (Other)v3 Show 4 more changesShow less
    • Secondary endpoints revised (12)
    • Primary endpoint revised
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 4 words
  3. Eligibility criteria expanded, about 17 words
    • Secondary endpoints revised (12)
    • Study description expanded, about 19 words
    • Study title revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sheba Medical Center
49 trials monitored
See all monitored trials
Diabetes
5,087 trials monitored
See 222 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
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.
Trial Details
NCT Number NCT06497595
Lead Sponsor Sheba Medical Center
Collaborators: Hadassah Medical Organization
Conditions
(from sponsor)		 Type 2 Diabetes Mellitus in Obese
Related terms Diabetes Mellitus, Type 2, Motor Activity, Obesity, Sarcopenia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov