- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04759755
Cirkadisk timing, informasjonsbehandling og energibalansestudie (TIME)
Døgn- og søvnveier til risiko for kardiometabolske sykdommer: Rollen til nevroatferdsprosesser
This study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic risk factors.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The goal of this study is to determine how sleep and circadian rhythm alignment contribute to neurobehavioral and behavioral mechanisms of cardiometabolic risk. The investigators propose that circadian misalignment, which is more common among individuals with late sleep timing, leads to increased consumption of energy dense/prepared foods and to decreased insulin sensitivity. Short sleep duration and neurobehavioral measures (i.e. delay discounting) may moderate these associations, thus exacerbating cardiometabolic risk factors. There is evidence for a direct biological link between circadian misalignment and insulin resistance, and for a relationship that is mediated through changes in eating behaviors. Insulin resistance and increased caloric intake over time lead to increased BMI and body fat.
In this study, the investigators will conduct cross-sectional and longitudinal analyses to determine biological and behavioral mechanisms that link circadian alignment and sleep duration to changes in cardiometabolic risk over 1 year. This study will identify individual differences that predict risk for cardiometabolic disorders and suggest potential for sleep, circadian and neurobehavioral interventions to reduce cardiometabolic risk.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Utah
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Salt Lake City, Utah, Forente stater, 84108
- University of Utah
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
community sample
Beskrivelse
Inclusion Criteria:
- Demonstrate habitual sleep onset time between 10:00 pm-3:00 am on actigraphy;
- able to read and write in English;
- BMI 25-39.9 (overweight, class one obesity, or class two obesity)
Exclusion Criteria:
- High risk or presence of sleep disorders (obstructive sleep apnea (OSA), restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight OSA screening;
- Diagnosed with diabetes or HbA1c>7 at screening or taking medications known to affect glucose;
- History of cognitive or neurological disorders;
- Presence of major psychiatric disorders, current alcohol or substance abuse as determined by screening questionnaires or self-report;
- Unstable or serious medical illness;
- Overnight shift work or travel over 2 time zones in the past 2 months;
- Use of hypnotic, stimulant or medications know to affect melatonin concentrations such as beta blockers, daily NSAIDs;
- Current smoking;
- Daily caffeine intake >300 mg;
- Pregnant or lactating;
- Currently on a restrictive of special diet.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: ECOLOGIC_OR_COMMUNITY
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
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Study participants
18-60 year olds who demonstrate habitual sleep onset time between 10:00 pm-3:00 am and BMI 25-39.9. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Glycemic Control (HbA1c)
Tidsramme: Cross-sectional analysis at baseline
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Measured by the A1C now test, a point of care blood spot test |
Cross-sectional analysis at baseline
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 00117438
- 1R01HL141706-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Data will be made available upon request
IPD-delingstidsramme
Data will be available within 1 year of completion of the study and will be available for 1 year
Tilgangskriterier for IPD-deling
Written request to the PI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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