[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557320":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":34,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal weight patients",null,"23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF.",[13],"Biological: Platelet rich growth factor injection (autologous product)",{"label":15,"type":10,"description":16,"interventionNames":17},"Over weight patients","23 subjects with BMI values that exceed the considered range normal weight, therefore with BMI\\>25, who undergo the PRGF treatment",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"BIOLOGICAL","Platelet rich growth factor injection (autologous product)","All patients will undergo two PRGF injections, one at recruitment and one 14 days after the first injection. The injection site will be the shoulder with tendinopathy.",[9,15],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Paola De Luca, PhD","CONTACT","+39 3921385179","deluca.paola@grupposandonato.it",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Michela Taiana, PhD","+39 3335952857","michelamaria.taiana@grupposandonato.it",[35],{"facility":5,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Milan","20173","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.18951,45.46427,{"lat":45,"lon":44},[48,52],{"name":49,"role":27,"phone":50,"phoneExt":10,"email":51},"Elena Cittera","00390283502224","elena.cittera@grupposandonato.it",{"name":53,"role":54,"phone":10,"phoneExt":10,"email":10},"Paola De Luca","PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100557320","nutrition-impact-on-prgf-treatment-for-tendinopathy-100557320",false,"NCT06536582","Nutrition Impact on PRGF Treatment for Tendinopathy","Nutrition as a Risk Factor and Predictor of Treatment Outcome With Plasma Rich Growth Factors for Shoulder Tendinopathy","NUTRITENDON","Inclusion Criteria:\n\n* Male and female\n* Age ≥18 years and ≤ 70 years\n* Patients presenting shoulder tendinopathy\n* Signing of the Informed Consent of the Regain observational study\n* Signature of informed consent of the present study.\n\nExclusion Criteria:\n\n* Pregnancy (ascertained by self-declaration), breastfeeding\n* Inability to follow the study protocol\n* Heart, kidney, oncological disease\n* Neuropsychiatric disease\n* Other conditions that, at the discretion of the investigator or physician, exclude enrollement",true,"ALL","18 Years","70 Years",{"count":70,"type":71},52,"ESTIMATED","OBSERVATIONAL","Given the close correlation reported in the literature between onset and progression of tendon pathology in subjects affected by the alteration of metabolic disorders such as obesity, diabetes mellitus and lipidic metabolic alterations, with the present study the association between the nutritional state, metabolic profile and clinical outcome of patients following treatment with blood-derived orthobiological for shoulder tendinopathies will be evaluated.\n\nThe primary aim of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with \"Platelet rich growth factors\" PRGF at six months follow up and the correlation with their nutritional status.",[75,76],"Shoulder Tendinopathy","Metabolic Alterations",[78,79,80,81],"nutritional status","responder and non-responder patients","orthobiologics","Platelet rich growth factors","2024-07-30",{"date":84,"type":85},"2024-08-05","ACTUAL",{"date":87,"type":85},"2024-02-15",{"date":89,"type":71},"2027-02-15",{"name":5,"class":6},1]