Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorAssaf-Harofeh Medical Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

significant renal or liver function abnormalities

head injuries,

epileptic episodes

psychiatric medications

Trial population

Patiets ages 12-18 years with type 1 diabetes mellitus and healthy controls same age and gender distribution

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

  • Reversed Circadian Rhythm

    Behavioral

    Revered day/ night sleep cycle

  • Normal Circadian Rhythm

    Behavioral

    Normal day/ night sleep cycle

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Normal Circardian rhythm1 intervention
Group B: Reversed circadian rhythm1 intervention

Trial outcomes

Primary outcomes

1

Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose

Score of neurocognitive tests for executive function according to day/night sleeping pattern session

Time frame
2 years
2

Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents .

Time spent in range of glucose of 70-180 mg/dl according to day/night sleeping pattern

Time frame
2 years
3

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.

Quality of sleep according to PSQI, according to day/night sleeping pattern

Time frame
2 years

Secondary outcomes

1

Melatonin profile according to night/day sleep cycle among healthy and among T1D patients

Differences in levels of melatonin in nmol/l between sessions and between health and T1D patients

Time frame
2 years
2

Temperature according to night/day sleep cycle among healthy and among T1D patients

Differences in peripheral body temperature (celzius) between sessions and between health and T1D patients

Time frame
2 years
3

EEG registration in accordance with the circadian curve and neurocognitive achievements

Power of high frequency amplitude between night/sleep sessions among T1D and healthy

Time frame
2 years
4

MRI structural changes

DT1-MRI trajectoris areas of supra-chiasmatic nuclei sleeping pattern session

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assaf-Harofeh Medical Center

Lead sponsor

Western University, Canada

Collaborator

Hadassah Medical Organization

Collaborator

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