Clinical trial NCT04054934: Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: T1DM
Sleep Disorders, Circadian Rhythm
ADHD
Memory Impairment
Keywords: T1DM
Hypothalamus
CORTICAL BRAIN
Glucose variability
Biological clock
Pediatrics
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Western University, Canada
name: Hadassah Medical Organization
First posted: 2019-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patiets ages 12-18 years with type 1 diabetes mellitus and healthy controls same age and gender distribution

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Families living in areas with high access to medical care.
* Age: 12-18 years old
* T1D diagnosis for longer than 1 year
* speaking fluent Hebrew

Exclusion Criteria:

* significant renal or liver function abnormalities
* head injuries,
* epileptic episodes
* psychiatric medications
* lack of Hebrew abilities
* disagreement to comply with all the study requests
* 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.

Primary outcomes:
measure: Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose
timeFrame: 2 years
measure: Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents .
timeFrame: 2 years
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
Secondary outcomes:
measure: Melatonin profile according to night/day sleep cycle among healthy and among T1D patients
timeFrame: 2 years
measure: Temperature according to night/day sleep cycle among healthy and among T1D patients
timeFrame: 2 years
measure: EEG registration in accordance with the circadian curve and neurocognitive achievements
timeFrame: 2 years
measure: MRI structural changes
timeFrame: 2 years
measure: Hormonal profile according to night/day sleep cycle among healthy and among T1D patients
timeFrame: 2 years
measure: Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients
timeFrame: 2 years
Other outcomes:
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