[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366720":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":10,"responsibleParty":39,"collaborators":43,"id":49,"slug":10,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":10},{"fullName":5,"class":6},"Assaf-Harofeh Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal Circardian rhythm",null,"Regular night sleep, with at least 7 hours length of sleep.",[13],"Behavioral: Normal Circadian Rhythm",{"label":15,"type":10,"description":16,"interventionNames":17},"Reversed circadian rhythm","Night\u002Fday circadian clock is opposite, with at least 7 hours length of sleep",[18],"Behavioral: Reversed Circadian Rhythm",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"BEHAVIORAL","Reversed Circadian Rhythm","Revered day\u002F night sleep cycle",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Normal Circadian Rhythm","Normal day\u002F night sleep cycle",[9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Marianna Rachmiel, M.D","CONTACT","+972-537346636","rmarianna@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Avital Leshem","+972-528303012","childendo.research@gmail.com",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Assaf Harofeh MC","Head of Pediatric Endocrinology Unit",[44,47],{"name":45,"class":46},"Western University, Canada","OTHER",{"name":48,"class":46},"Hadassah Medical Organization","100366720",false,"NCT04054934","Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes","Influence of Circadian Clock on Diurnal Dietary Intake, Glucose Variability, Time Spent in Range, and Neuro-cognitive Achievements Among Adolescents With and Without Type 1 Diabetes","Inclusion Criteria:\n\n* Families living in areas with high access to medical care.\n* Age: 12-18 years old\n* T1D diagnosis for longer than 1 year\n* speaking fluent Hebrew\n\nExclusion Criteria:\n\n* significant renal or liver function abnormalities\n* head injuries,\n* epileptic episodes\n* psychiatric medications\n* lack of Hebrew abilities\n* disagreement to comply with all the study requests\n* history of more than one episode of a severe hypoglycemic event in the past, including loss of consciousness or more than one episode of diabetic ketoacidosis.",true,"ALL","12 Years","18 Years",{"count":60,"type":61},100,"ESTIMATED","OBSERVATIONAL","Type 1 diabetes mellitus (T1DM), makes its appearance during childhood and youth, but management implications last till late adulthood. Its treatment includes the combination of multiple daily glucose measurements, insulin administration and balanced nutrition. The goals of therapy are to achieve glycemic control (HbA1c \\\u003C 7.5%), and minimal glycemic excursions. Furthermore, recent studies imply that keeping HbA1c within target range is not sufficient to prevent complications, attributed mainly to blood glucose level fluctuating from high to low, associated with food intake and adolescents behavior. The current implication of glycemic control on the central nervous system (CNS) includes abnormal electrical brain activity, structural changes in brain's white and grey matter, and cognitive impairment. Still, little is known on the effect of sleep pattern, including circadian rhythm reversal (\"biological clock) on asymptomatic glycemic excursions, and on CNS functions. There is no data regarding the association of the biologic clock on CNS functionality among adolescents, nonetheless among T1DM adolescents, for whom behavior and circadian rhythm alterations may have harmful effect. The investigators propose a cross-over designed study by examining adolescents with and without T1DM during 2 weeks of regular sleeping pattern (night sleep), and during 2 weeks of sleeping during the day as happens during summer vacation. The main objective of the proposed study is to offer proof of the clinical and metabolic relevance and cognitive effects of the reversal of the circadian clock in adolescents with and T1DM during summer vacations and weekends. Study is designed to demonstrate a difference among healthy and diabetics during reversed night\u002Fday circadian clocks in the time spent within target range of glucose, performance on neuro cognitive tasks, electrical brain activity, and hormonal profile.",[65,66,67,68],"T1DM","Sleep Disorders, Circadian Rhythm","ADHD","Memory Impairment",[65,70,71,72,73,74],"Hypothalamus","CORTICAL BRAIN","Glucose variability","Biological clock","Pediatrics","NOT_YET_RECRUITING","2020-05-22",{"date":78,"type":79},"2020-05-26","ACTUAL",{"date":81,"type":61},"2022-01",{"date":83,"type":61},"2026-12",{"name":5,"class":6}]