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

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

Sponsors

Lead Sponsor: Assaf-Harofeh Medical Center

Collaborator: Western University, Canada
Hadassah Medical Organization

Source Assaf-Harofeh Medical Center
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.

Overall Status Not yet recruiting
Start Date January 2022
Completion Date December 2026
Primary Completion Date December 2026
Study Type Observational
Primary Outcome
Measure Time Frame
Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose 2 years
Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents . 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. 2 years
Secondary Outcome
Measure Time Frame
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
Enrollment 100
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Reversed Circadian Rhythm

Description: Revered day/ night sleep cycle

Arm Group Label: Reversed circadian rhythm

Intervention Type: Behavioral

Intervention Name: Normal Circadian Rhythm

Description: Normal day/ night sleep cycle

Arm Group Label: Normal Circardian rhythm

Eligibility

Sampling Method: Probability Sample

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.

Gender: All

Minimum Age: 12 Years

Maximum Age: 18 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Marianna Rachmiel, M.D

Phone: +972-537346636

Email: [email protected]

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assaf-Harofeh Medical Center

Investigator Full Name: Assaf Harofeh MC

Investigator Title: Head of Pediatric Endocrinology Unit

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Normal Circardian rhythm

Description: Regular night sleep, with at least 7 hours length of sleep.

Label: Reversed circadian rhythm

Description: Night/day circadian clock is opposite, with at least 7 hours length of sleep

Study Design Info

Observational Model: Case-Crossover

Time Perspective: Prospective

Source: ClinicalTrials.gov