Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

22. mai 2020 oppdatert av: Assaf Harofeh MC, Assaf-Harofeh Medical Center

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

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.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Forventet)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Patiets ages 12-18 years with type 1 diabetes mellitus and healthy controls same age and gender distribution

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Normal Circardian rhythm
Regular night sleep, with at least 7 hours length of sleep.
Normal day/ night sleep cycle
Reversed circadian rhythm
Night/day circadian clock is opposite, with at least 7 hours length of sleep
Revered day/ night sleep cycle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose
Tidsramme: 2 years
Score of neurocognitive tests for executive function according to day/night sleeping pattern session
2 years
Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents .
Tidsramme: 2 years
Time spent in range of glucose of 70-180 mg/dl according to day/night sleeping pattern
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.
Tidsramme: 2 years
Quality of sleep according to PSQI, according to day/night sleeping pattern
2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Melatonin profile according to night/day sleep cycle among healthy and among T1D patients
Tidsramme: 2 years
Differences in levels of melatonin in nmol/l between sessions and between health and T1D patients
2 years
Temperature according to night/day sleep cycle among healthy and among T1D patients
Tidsramme: 2 years
Differences in peripheral body temperature (celzius) between sessions and between health and T1D patients
2 years
EEG registration in accordance with the circadian curve and neurocognitive achievements
Tidsramme: 2 years
Power of high frequency amplitude between night/sleep sessions among T1D and healthy
2 years
MRI structural changes
Tidsramme: 2 years
DT1-MRI trajectoris areas of supra-chiasmatic nuclei sleeping pattern session
2 years
Hormonal profile according to night/day sleep cycle among healthy and among T1D patients
Tidsramme: 2 years
Differences in levels of cortisol in nmol/l between sessions and between health and T1D patients
2 years
Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients
Tidsramme: 2 years
Differences in blood pressure (mmHG) between sessions and between health and T1D patients
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. januar 2022

Primær fullføring (Forventet)

1. desember 2026

Studiet fullført (Forventet)

1. desember 2026

Datoer for studieregistrering

Først innsendt

26. mai 2019

Først innsendt som oppfylte QC-kriteriene

10. august 2019

Først lagt ut (Faktiske)

13. august 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på ADHD

Kliniske studier på Normal Circadian Rhythm

3
Abonnere