[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509083":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":25,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":10,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Sarcopenic obesity",null,"BMI\\>30, bioelectric impedance positive for sarcopenic obesity (FM% \\[fat mass percentage\\] female \\>43%, male \\>31% AND SMM\u002FW \\[skeletal muscle mass\u002Fweight\\] female \\\u003C28%, male \\\u003C37%), any one of the physical performance test positive (5-times chair stand test \\>17 s OR handgrip strength test \\\u003C35,5 kg for males, \\\u003C20 kg for females).",{"label":13,"type":10,"description":14,"interventionNames":10},"Non-sarcopenic obesity","BMI\\>30, bioelectric impedance negative for sarcopenic obesity.",[16],{"name":17,"affiliation":18,"role":19},"Francesco Giorgino, MD, PhD","Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari","PRINCIPAL_INVESTIGATOR",[21],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","+390805593522","francesco.giorgino@uniba.it",[26],{"facility":27,"status":28,"city":29,"state":10,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Policlinico di Bari","RECRUITING","Bari","70124","Italy","IT",{"type":34,"coordinates":35},"Point",[36,37],16.86982,41.12066,{"lat":37,"lon":36},[40],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100509083","relationship-between-glycemic-control-and-irisin-in-type-2-diabetic-patients-with-sarcopenic-or-non-sarcopenic-obesity-100509083",false,"NCT05908812","Relationship Between Glycemic Control and Irisin in Type 2 Diabetic Patients With Sarcopenic or Non-sarcopenic Obesity","Relationship Between Parameters of Glycemic Control and Irisin Levels in Patients With Diabetes Mellitus Type 2 and Sarcopenic Obesity or Non-sarcopenic Obesity","Inclusion Criteria:\n\n* Diabetes mellitus type 2 diagnosed less than 10 years before\n* age \\>60 years\n* BMI (Body Mass Index) \\>30 kg\u002Fm2\n* eGFR (estimated Glomerular Filtration Rate) \\>30 ml\u002Fmin\n* On stable antidiabetic therapy for at least 3 months\n\nExclusion Criteria:\n\n* Insulin or insulin secretagogues use\n* Diabetes mellitus type 1, previous diabetic ketoacidosis\n* Neuromuscular diseases\n* Endocrinopathies that may cause myopathies (hypercortisolism, GH \\[growth hormone\\] deficiency, acromegaly, adrenal insufficiency, partial hypopituitarism or panhypopituitarism, male hypogonadism, hyperparathyroidism, hypoparathyroidism)\n* Severe vit. D deficiency (\\\u003C12 ng\u002Fml)\n* Hemoglobinopathies\n* Prolonged immobilization\n* Pathologies with fluid retention (heart failure with NYHA \\[New York Heart Association\\] class III\u002FIV, severe renal insufficiency, hepatic insufficiency)\n* Active tumors in the past 5 years\n* Severe arthritis of the knee or hip\n* Pacemaker wearer","ALL","60 Years",{"count":53,"type":54},120,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to compare glycemic control and irisin levels in subjects with diabetes mellitus type 2 with sarcopenic obesity vs non-sarcopenic obesity.\n\nThe main questions it aims to answer are:\n\nIs glycemic control worse in diabetic patients with sarcopenic obesity? Are irisin levels higher in patients with non-sarcopenic obesity?\n\nParticipants will be asked to:\n\n* Fill in three questionaries on lifestyle\n* Perform two physical performance tests\n\nThe investigators will collect the following data:\n\n* Anthropometric measurements\n* Body composition by bioelectrical impedance analysis.\n* Results of routine blood analyses\n* Irisin levels by drawing a vial of blood from the antecubital vein",[58,59,60],"Sarcopenia","Obesity","Diabetes Mellitus, Type 2",[62,63,64],"Irisin protein","Hand Strength [E01.370.600.425.500]","Glycated Hemoglobin [D23.946.381.625.500.250]","2024-07-31",{"date":67,"type":68},"2024-08-01","ACTUAL",{"date":70,"type":68},"2023-02-01",{"date":72,"type":54},"2025-01-31",{"name":5,"class":6},1]