[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509083":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":16,"studyPopulation":17,"armGroups":18,"interventions":13,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":51,"collaborators":13,"id":53,"slug":13,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":13,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":13,"enrollmentInfo":61,"targetDuration":13,"studyType":64,"phases":13,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":38,"whyStopped":13,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Differences in glycated hemoglobin and\u002For insulin resistance in diabetic patients with non-sarcopenic obesity vs patients with sarcopenic obesity","Differences in glycated hemoglobin or in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) in patients with sarcopenic obesity vs non-sarcopenic obesity","Baseline",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":6,"maskingInfo":13},"CASE_CONTROL","Patients will be enrolled from our Diabetology Center. Eligible patients will be contacted by phone to be informed of the procedures and to schedule the visit.\n\nThe patients will come to the visit bringing the blood analyses they usually bring for the routine diabetologic visit; they will also be fasting for at least 3 hours, and abstaining from smoking and physical activity since the day before. All visits will be performed in the afternoon, at about 4-6 p.m.\n\nParticipants will be asked to:\n\n* Fill in three questionaries (SARC-F \\[Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire\\], IPAQ-EIT \\[International Physical Activity Questionnaire validated in the Elderly Italian population\\], MEDI-LITE \\[Adherence to the Mediterranean diet questionnaire\\])\n* Perform two physical performance tests (5-times chair stand test and handgrip test).\n\nAnthropometric measurements will be assessed; body composition will be evaluated by bioelectrical impedance analysis. A venous blood draw will be executed for evaluation of irisin levels after signing a written consent form.","Patients will be selected from our Center's patients. A physician will screen the eligible patients from the automatic search on the database from the program Smart Digital Clinic.",[19,22],{"label":20,"type":13,"description":21,"interventionNames":13},"Sarcopenic obesity","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":23,"type":13,"description":24,"interventionNames":13},"Non-sarcopenic obesity","BMI\\>30, bioelectric impedance negative for sarcopenic obesity.",[26],{"name":27,"affiliation":28,"role":29},"Francesco Giorgino, MD, PhD","Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":13,"email":34},"CONTACT","+390805593522","francesco.giorgino@uniba.it",[36],{"facility":37,"status":38,"city":39,"state":13,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Policlinico di Bari","RECRUITING","Bari","70124","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],16.86982,41.12066,{"lat":47,"lon":46},[50],{"name":27,"role":32,"phone":33,"phoneExt":13,"email":34},{"type":52,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","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":62,"type":63},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",[67,68,69],"Sarcopenia","Obesity","Diabetes Mellitus, Type 2",[71,72,73],"Irisin protein","Hand Strength [E01.370.600.425.500]","Glycated Hemoglobin [D23.946.381.625.500.250]","2024-07-31",{"date":76,"type":77},"2024-08-01","ACTUAL",{"date":79,"type":77},"2023-02-01",{"date":81,"type":63},"2025-01-31",{"name":5,"class":6},1]