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NCT Number: NCT04054934

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reversed Circadian Rhythm

Behavioral

Revered day/ night sleep cycle

Normal Circadian Rhythm

Behavioral

Normal day/ night sleep cycle

Primary outcomes

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

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  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.

    Time frame: 2 years

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

Secondary outcomes

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

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  3. EEG registration in accordance with the circadian curve and neurocognitive achievements

    Time frame: 2 years

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

  4. MRI structural changes

    Time frame: 2 years

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

  5. Hormonal profile according to night/day sleep cycle among healthy and among T1D patients

    Time frame: 2 years

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

  6. Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients

    Time frame: 2 years

    Differences in blood pressure (mmHG) between sessions and between health and T1D patients

Study contacts

Contact information is provided by the study sponsor or research team.

Avital Leshem

CONTACT

[email protected]

+972-528303012

Marianna Rachmiel, M.D

CONTACT

[email protected]

+972-537346636

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Collaborators

  • Hadassah Medical Organization
  • Western University, Canada

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2019
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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