Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reversed Circadian Rhythm, Normal Circadian Rhythm.
- Who it may be relevant to
- Registry conditions: T1DM, Sleep Disorders, Circadian Rhythm, ADHD, Memory Impairment. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral Reversed Circadian Rhythm
Revered day/ night sleep cycle - Behavioral Normal Circadian Rhythm
Normal day/ night sleep cycle
Primary outcome measures
- Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose [Time frame: 2 years]
- Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents . [Time frame: 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. [Time frame: 2 years]
Secondary outcome measures (6)
- Melatonin profile according to night/day sleep cycle among healthy and among T1D patients [Time frame: 2 years]
- Temperature according to night/day sleep cycle among healthy and among T1D patients [Time frame: 2 years]
- EEG registration in accordance with the circadian curve and neurocognitive achievements [Time frame: 2 years]
- MRI structural changes [Time frame: 2 years]
- Hormonal profile according to night/day sleep cycle among healthy and among T1D patients [Time frame: 2 years]
- Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-crossover
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04054934 · 0291-18