跳至主要内容
临床试验/NCT04054934
NCT04054934尚未招募不适用

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

Assaf-Harofeh Medical Center0 个研究点目标入组 100 人开始时间: 2022年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 2 years

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

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

时间窗: 2 years

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

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.

时间窗: 2 years

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

次要结局

  • 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)
  • Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients(2 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Assaf Harofeh MC

Head of Pediatric Endocrinology Unit

Assaf-Harofeh Medical Center

相似试验