[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554323":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":73,"collaborators":76,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":26,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":106,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"multi-disciplinary intervention group (MDIG)","EXPERIMENTAL","Participants in this group will receive Semaglutide 2.4 mg SC QW and take part in a multi-disciplinary intervention comprised of home-based exercise and nutritional counselling for the 26-week trial duration.",[13],"Behavioral: Wegovy (2.4 Mg Dose) + exercise & nutrition",{"label":15,"type":16,"description":17,"interventionNames":18},"general health recommendations control group (GHRG)","ACTIVE_COMPARATOR","Participants in this group will receive Semaglutide 2.4 mg SC QW and general health recommendations for the 26-week trial duration.",[19],"Other: Wegovy (2.4 Mg Dose) + usual care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Wegovy (2.4 Mg Dose) + exercise & nutrition","Participants 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.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Wegovy (2.4 Mg Dose) + usual care","Participants 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\u002Fweek, with no more than 2 consecutive days without activity, or engage in 75 minutes\u002Fweek of vigorous-intensity or interval training (for more physically fit individuals). Incorporate 2-3 sessions\u002Fweek of resistance exercise on nonconsecutive days, decrease sedentary behavior and add flexibility and balance training 2-3 times\u002Fweek. 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.",[15],[33],{"name":34,"affiliation":35,"role":36},"Tali Cukierman - Yaffe, professor","Division of Endocrinology, Sheba Medical Center, Israel.","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","0523824704","tcukierm@gmail.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Tal Yahalom-Peri","0544647640","Tal.yahalom@gmail.com",[47,64],{"facility":48,"status":26,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hadassah Medical Center","Jerusalem","5251108","Israel","IL",{"type":54,"coordinates":55},"Point",[56,57],35.21633,31.76904,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":62,"phoneExt":26,"email":63},"Genya Aharon - Hananel, Dr.","+972 52-557-6455","Genyah@hadassah.org.il",{"facility":65,"status":26,"city":66,"state":26,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":26},"Sheba medical center","Ramat Gan","52621",{"type":54,"coordinates":69},[70,71],34.81065,32.08227,{"lat":71,"lon":70},{"type":36,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr. Tali Cukierman-Yaffe","professor",[77],{"name":78,"class":28},"Hadassah Medical Organization","100554323","lifestyle-intervention-to-reduce-the-risk-of-sarcopenia-in-adults-with-diabetes--obesity-treated-with-semaglutide-100554323",false,"NCT06497595","Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide","Exercise and Nutritional Intervention to Reduce the Risk of Sarcopenia in Older Adults With Type 2 Diabetes and Obesity Treated With Semaglutide: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients 65-75 years old.\n2. Patients who were previously diagnosed with type 2 diabetes.\n3. Overweight \u002F obesity (body mass index, BMI ≥ 27 kg\u002Fm2).\n\nExclusion Criteria:\n\n1. Patients with significant hearing or visual disability.\n2. Patients with Estimated Glomerular Filtration Rate (eGFR)\\\u003C30 ml\u002Fmin\u002F1.73 m2.\n3. Patients who are in active nutritional therapy.\n4. Patients who changed their diet recently (\\\u003C 1 month) and\u002For in a weight-loss program with \\>5% weight loss or used anti-obesity drugs in the last 3 months.\n5. Patients who reported a weight loss of \\>5kg within 90 days of screening\n6. Patients who were on Glucagon-like peptide-1 receptor agonists (GLP-1-RA) treatment during the last 3 months.\n7. Patients with musculoskeletal disorders, which, by the judgment of the investigators, would limit their ability to perform the exercise training.\n8. Patients with neurological diseases, which by the judgment of the investigators, would affect their ability to participate in the trial.\n9. Patients with a history of amputation that impairs their ability to participate in the exercise program.\n10. Patients with disabilities, which, by the judgment of the investigators, would affect their ability to participate in the trial.\n11. Patients who use a walking aid.\n12. Patients who are currently using systemic steroids.\n13. Patients with active oncological diseases, excluding non-melanoma skin cancer.\n14. Patients with diagnosed dementia or cognitive impairment that, in the view of the researchers, may impair their ability to sign a consent form or participate in the trial.\n15. Patients who were hospitalized in the past month.\n16. Patients who exercise regularly and in the eyes of the examiner will not benefit from the intervention program.\n17. Anyone who is not suitable to participate in the study, according to the researcher's discretion.\n18. Any contraindication to Magnetic resonance imaging (MRI) (e.g., MRI non-compatible cardiac implantable electronic device, metallic foreign bodies, implantable neurostimulation system, cochlear implants\u002Fear implant, non-removable drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips which), or inability to perform an MRI scanner (e.g., claustrophobia).\n19. Patients who do not fit within the measurement field of view of the Dual-energy X-ray absorptiometry (DXA) scanner in a supine position with the arms next to the body.","ALL","65 Years","75 Years",{"count":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[94],"NA","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.\n\nThe main questions it aims to answer are:\n\nIn older people with T2D and obesity, treated with Semaglutide, does a multi-disciplinary intervention of exercise and nutrition compared to standard health recommendations:\n\n1. Reduce the rate of decline in muscle mass?\n2. Reduce the rate of decline in muscle strength?\n3. Reduce the rate of decline in physical function?\n\nParticipants will:\n\nAdminister 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.",[97],"Type 2 Diabetes Mellitus in Obese",[99,100,101,102,103,104,105],"older adults","sarcopenia","obesity","type 2 diabetes","semaglutide","exercise","physical capacity","NOT_YET_RECRUITING","2024-08-20",{"date":109,"type":110},"2024-08-22","ACTUAL",{"date":112,"type":91},"2024-08-30",{"date":114,"type":91},"2025-08-30",{"name":5,"class":6},2]