[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100287519":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":65,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":10,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Heidelberg University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with diabetes",null,"Patients with both type 1 and type 2 Diabetes will be enrolled, Independent of Diabetes Duration, therapy etc.\n\nNo interventions are planned.",[13],"Other: No interventions are planned for this study.",{"label":15,"type":10,"description":16,"interventionNames":17},"Pre-Diabetics","Patients who have either imparied fasting Glucose or impaired Glucose tolerance in the oral Glucose tolerance test.\n\nNo interventions are planned.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Healthy controls","Study participants without Diabetes or Pre-diabetes in the oral Glucose tolerance test.\n\nno interventions are planned.",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"No interventions are planned for this study.","No interventions are planned for this study, it is purely observational.",[19,9,15],[28],{"name":29,"affiliation":30,"role":31},"Stefan Kopf, MD","Head of the Clinical Study Center for Diabetes Research","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","+49-6221-56","37790","stefan.kopf@med.uni-heidelberg.de",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Jan B Groener, MD","37639","jan.groener@med.uni-heidelberg.de",[43],{"facility":44,"status":45,"city":46,"state":10,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Department of Medicine, University of Heidelberg","RECRUITING","Heidelberg","69120","Germany","DE",{"type":51,"coordinates":52},"Point",[53,54],8.69079,49.40768,{"lat":54,"lon":53},[57,59,60,61,63],{"name":29,"role":34,"phone":58,"phoneExt":36,"email":37},"+49-6221-",{"name":39,"role":34,"phone":58,"phoneExt":40,"email":41},{"name":29,"role":31,"phone":10,"phoneExt":10,"email":10},{"name":39,"role":62,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":64,"role":62,"phone":10,"phoneExt":10,"email":10},"Peter P Nawroth, Prof.",{"type":31,"investigatorFullName":66,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Stefan Kopf MD","100287519","heidelberg-study-on-diabetes-and-complications-100287519",false,"NCT03022721","Heidelberg Study on Diabetes and Complications","HEIST-DiC","Inclusion Criteria Age between 18 and 75 years Persons with manifest diabetes mellitus type 1 or type 2 and diagnosis according to DDG guidelines 2011, that is HbA1c of 6,5 percent or higher after exclusion of false values, more than 200 mg per dl two hours after glucose in the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice Healthy persons without diabetes or impairment of glucose metabolism in the oGTT according to DDG guidelines 2011 fasting plasma glucose less than 100 mg per dl and 2 hour plasma glucose less than 140 mg per dl Pre diabetics with impaired fasting glucose between 100 mg per dl and 125 mg per dl, or impaired glucose tolerance with 2 hour glucose values between 140 and 199 mg per dl in the oGTT, all values from venous plasma\n\nExclusion Criteria General exclusion criteria Secondary types of Diabetes, ADA criteria type 3 B H Current pregnancy Acute infections or fever Immune suppressant therapy Severe psychiatric diseases requiring treatment, including personality disorders, schizophrenia, depression Known alcohol or drug dependency Severe heart NYHA stadium IV, kidney, or liver insufficiency Non diabetic liver disease, for example PBC, PSC, Wilsons disease, hemochromatosis, autoimmune hepatitis severe peripheral artery disease stadium IV non diabetic glomerulopathy Cancer or other malignant diseases within the last 5 years Infectious diseases like hepatitis B, C, E, or HIV Other severe autoimmune diseases Current participation in an interventional study Anemia or disorders of bone marrow Exclusion criteria for MRI Pacemaker or ICD Metallic and magnetic implants, for example mechanic cardiac valves replacements, joint prostheses, clips after vascular surgery, middle or inner ear implants, recent tooth implants, penile implants Waist circumference more than 135 cm Claustrophobia Allergies against MRI contrast Impaired kidney function with a GFR less than 65 ml per min\n\nExclusion criteria for clamp study Past history of deep vein thrombosis or pulmonary embolism Routine laboratory test results less than 80 percent below lower reference value of Ferritin, iron, leucocytes, hemoglobin, hematocrite, RBC, platelets, blood alcohol Level\n\nExclusion criteria for bioimpedance measurement Pacemaker or ICD\n\nExclusion criteria for lung function testing Ignoring or non understanding of the instructions Body weight more than 160 kg",true,"ALL","18 Years","75 Years",{"count":79,"type":80},500,"ESTIMATED","OBSERVATIONAL","The prospective observational study entitled \"Heidelberg Study on Diabetes and Complications\" is designed to Monitor the presence and development of diabetic complications in type 1 and type 2 diabetic patients, as well as pre-diabetics. Mail Goal is to detect new metabolic mechanisms or new risk factors for the development of diabetic complications in order to identify risk-subgroups. Non-diabetic controls will be enrolled for reference and comparison.",[84],"Diabetes Complications","2017-01-12",{"date":87,"type":80},"2017-01-16",{"date":89,"type":10},"2016-09",{"date":91,"type":80},"2028-09",{"name":5,"class":6},1]