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Набор скоро начнётся NCT04054934

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

— Наблюдательное T1DM Sleep Disorders, Circadian Rhythm ADHD Memory Impairment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Reversed Circadian Rhythm, Normal Circadian Rhythm.
Кому может быть актуально
Состояния в реестре: T1DM, Sleep Disorders, Circadian Rhythm, ADHD, Memory Impairment. Базовые параметры: 12 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое Reversed Circadian Rhythm
    Revered day/ night sleep cycle
  • Поведенческое Normal Circadian Rhythm
    Normal day/ night sleep cycle

Первичные конечные точки

  • Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose [Срок оценки: 2 years]
  • Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents . [Срок оценки: 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. [Срок оценки: 2 years]
Вторичные конечные точки (6)
  • Melatonin profile according to night/day sleep cycle among healthy and among T1D patients [Срок оценки: 2 years]
  • Temperature according to night/day sleep cycle among healthy and among T1D patients [Срок оценки: 2 years]
  • EEG registration in accordance with the circadian curve and neurocognitive achievements [Срок оценки: 2 years]
  • MRI structural changes [Срок оценки: 2 years]
  • Hormonal profile according to night/day sleep cycle among healthy and among T1D patients [Срок оценки: 2 years]
  • Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-кроссовер

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04054934 · 0291-18

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗