Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2022
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 26, 2020
May 1, 2020
4.9 years
May 26, 2019
May 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
2 years
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
2 years
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
2 years
Secondary Outcomes (6)
Melatonin profile according to night/day sleep cycle among healthy and among T1D patients
2 years
Temperature according to night/day sleep cycle among healthy and among T1D patients
2 years
EEG registration in accordance with the circadian curve and neurocognitive achievements
2 years
MRI structural changes
2 years
Hormonal profile according to night/day sleep cycle among healthy and among T1D patients
2 years
- +1 more secondary outcomes
Study Arms (2)
Normal Circardian rhythm
Regular night sleep, with at least 7 hours length of sleep.
Reversed circadian rhythm
Night/day circadian clock is opposite, with at least 7 hours length of sleep
Interventions
Eligibility Criteria
Patiets ages 12-18 years with type 1 diabetes mellitus and healthy controls same age and gender distribution
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assaf-Harofeh Medical Centerlead
- Western University, Canadacollaborator
- Hadassah Medical Organizationcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pediatric Endocrinology Unit
Study Record Dates
First Submitted
May 26, 2019
First Posted
August 13, 2019
Study Start
January 1, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 26, 2020
Record last verified: 2020-05