Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-31 @ 3:23 AM
Study NCT ID:
NCT04054934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-05-26
First Post:
2019-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020178', 'term': 'Sleep Disorders, Circadian Rhythm'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2019-05-26', 'studyFirstSubmitQcDate': '2019-08-10', 'lastUpdatePostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose', 'timeFrame': '2 years', 'description': 'Score of neurocognitive tests for executive function according to day/night sleeping pattern session'}, {'measure': 'Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents .', 'timeFrame': '2 years', 'description': 'Time spent in range of glucose of 70-180 mg/dl according to day/night sleeping pattern'}, {'measure': 'Affects of reversal circadian clock on sleep quality among both healthy and T1DM adolescents (mainly T1DM), controlled for BMI-SDS, and mean HbA1c in T1D patients.', 'timeFrame': '2 years', 'description': 'Quality of sleep according to PSQI, according to day/night sleeping pattern'}], 'secondaryOutcomes': [{'measure': 'Melatonin profile according to night/day sleep cycle among healthy and among T1D patients', 'timeFrame': '2 years', 'description': 'Differences in levels of melatonin in nmol/l between sessions and between health and T1D patients'}, {'measure': 'Temperature according to night/day sleep cycle among healthy and among T1D patients', 'timeFrame': '2 years', 'description': 'Differences in peripheral body temperature (celzius) between sessions and between health and T1D patients'}, {'measure': 'EEG registration in accordance with the circadian curve and neurocognitive achievements', 'timeFrame': '2 years', 'description': 'Power of high frequency amplitude between night/sleep sessions among T1D and healthy'}, {'measure': 'MRI structural changes', 'timeFrame': '2 years', 'description': 'DT1-MRI trajectoris areas of supra-chiasmatic nuclei sleeping pattern session'}, {'measure': 'Hormonal profile according to night/day sleep cycle among healthy and among T1D patients', 'timeFrame': '2 years', 'description': 'Differences in levels of cortisol in nmol/l between sessions and between health and T1D patients'}, {'measure': 'Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients', 'timeFrame': '2 years', 'description': 'Differences in blood pressure (mmHG) between sessions and between health and T1D patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T1DM', 'Hypothalamus', 'CORTICAL BRAIN', 'Glucose variability', 'Biological clock', 'Pediatrics'], 'conditions': ['T1DM', 'Sleep Disorders, Circadian Rhythm', 'ADHD', 'Memory Impairment']}, 'descriptionModule': {'briefSummary': '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 \\< 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/day circadian clocks in the time spent within target range of glucose, performance on neuro cognitive tasks, electrical brain activity, and hormonal profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patiets ages 12-18 years with type 1 diabetes mellitus and healthy controls same age and gender distribution', 'healthyVolunteers': True, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT04054934', 'briefTitle': 'Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '0291-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Circardian rhythm', 'description': 'Regular night sleep, with at least 7 hours length of sleep.', 'interventionNames': ['Behavioral: Normal Circadian Rhythm']}, {'label': 'Reversed circadian rhythm', 'description': 'Night/day circadian clock is opposite, with at least 7 hours length of sleep', 'interventionNames': ['Behavioral: Reversed Circadian Rhythm']}], 'interventions': [{'name': 'Reversed Circadian Rhythm', 'type': 'BEHAVIORAL', 'description': 'Revered day/ night sleep cycle', 'armGroupLabels': ['Reversed circadian rhythm']}, {'name': 'Normal Circadian Rhythm', 'type': 'BEHAVIORAL', 'description': 'Normal day/ night sleep cycle', 'armGroupLabels': ['Normal Circardian rhythm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marianna Rachmiel, M.D', 'role': 'CONTACT', 'email': 'rmarianna@gmail.com', 'phone': '+972-537346636'}, {'name': 'Avital Leshem', 'role': 'CONTACT', 'email': 'childendo.research@gmail.com', 'phone': '+972-528303012'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Western University, Canada', 'class': 'OTHER'}, {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pediatric Endocrinology Unit', 'investigatorFullName': 'Assaf Harofeh MC', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}