[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602221":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gravitostatic group (with mechanical load involving the use of a weighted vest)","EXPERIMENTAL",null,[13],"Other: maintaining mechanical load",{"label":15,"type":16,"description":11,"interventionNames":11},"Non-gravitostatic group (control group)","NO_INTERVENTION",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"maintaining mechanical load","The method for maintaining mechanical load (artificially reproducing the stabilization of initial body weight) will involve the use of a weighted vest.\n\nParticipants will be asked to wear the weighted vest for at least eight hours a day over a four-week period without changing their lifestyle. Patients will also be contacted by phone every week after surgery to confirm that they are using the vest in accordance with the protocol and to collect information on any potential adverse events. During these calls, weight adjustments-based on body weight changes-will be discussed with the patient and regularly recorded to stay as close as possible to the initial body weight, with a tolerance of ±1 kg. However, the maximum weight of the vest will not exceed 15% of the patient's initial weight (weight at the time of surgery).\n\nBetween the 4th and 12th week, patients will be asked to wear the weighted vest loaded with the \"weight lost\" calculated at week 4 for at least four hours per day.",[9],[23],{"name":24,"affiliation":5,"role":25},"Yves BOIRIE","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Lise Laclautre","CONTACT","334.73.754.963","promo_interne_drci@chu-clermontferrand.fr",[33],{"facility":34,"status":11,"city":35,"state":11,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"CHU Clermont-Ferrand","Clermont-Ferrand","France","FR",{"type":39,"coordinates":40},"Point",[41,42],3.08682,45.77969,{"lat":42,"lon":41},[45,47],{"name":24,"role":29,"phone":11,"phoneExt":11,"email":46},"yboirie@chu-clermontferrand.fr",{"name":24,"role":25,"phone":11,"phoneExt":11,"email":11},{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100602221","proof-of-concept-in-the-prevention-of-post-bariatric-sarcopenia-simulated-activation-of-the-gravitostat-100602221",false,"NCT07120685","Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the \"Gravitostat\"","Proof of Concept in the Prevention of Post-bariatric Sarcopenia: Simulated Activation of the \"Gravitostat\", Randomized Pilot Study","GRAVITOSARC","Inclusion Criteria:\n\n* Female participants\n* Aged between 18 and 60 years\n* Planned for bariatric surgery, such as sleeve gastrectomy\n* Able to give informed consent to participate in research\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Women weighing 170 kg or more\n* Inability to move around independently.\n* Participants with a spinal pathology.\n* Pregnant or breast-feeding women.\n* Inability to comply with protocol recommendations.\n* Adults under legal guardianship (curatorship, guardianship, deprivation of liberty, patients benefiting from a judicial protection measure or safeguard of justice).\n* Refusal to participate.","FEMALE","18 Years","60 Years",{"count":62,"type":63},40,"ESTIMATED","INTERVENTIONAL",[66],"NA","Due to its mechanical and metabolic functions, muscle loss leads to resistance to weight loss during caloric restriction, particularly in patients with obesity. The recent discovery of a \"gravitational\" homeostatic system, induced by an additional load to body weight, suggests the existence of a new weight control mechanism. Such a \"gravitostat\" would ensure a form of weight homeostasis mediated by afferent signals originating from osteocytes in response to gravity perception. This hypothesis, initially derived from animal studies, has more recently been tested in humans. It shows that \"activation of the gravitostat\" through artificial increases in body weight facilitates body weight reduction without affecting lean mass (LM). Therefore, this \"gravitostat\" could contribute to preserving LM despite the loss of fat mass , whereas its decline may compromise muscle mass and function after bariatric surgery, despite undeniable improvements in comorbidities.\n\nThe present study aims to reduce the \"metabolic load\" (i.e., decreasing insulin resistance and inflammation) to promote muscle protein anabolism, while maintaining the \"mechanical load\" (by preserving initial body weight during weight loss induced by bariatric surgery) in order to activate the \"gravitostat\" and preserve muscle mass and function.\n\nCurrently, there are no clear recommendations or strategies to prevent muscle loss in patients who have undergone bariatric surgery. This simple concept, applied during drastic muscle loss, should help improve muscle health.",[69,70],"Obesity &Amp; Overweight","Bariatric Surgery","NOT_YET_RECRUITING","2025-08-06",{"date":74,"type":75},"2025-08-13","ACTUAL",{"date":77,"type":63},"2025-09",{"date":79,"type":63},"2027-11",{"name":5,"class":6},1]