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Sleep Restriction and Obesity

18. januar 2022 opdateret af: Virend Somers, MD, PhD, Mayo Clinic
Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators hypothesize that sleep restriction will result in increased energy balance.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Numerous studies have reported that self-reported short sleep duration is associated with obesity and weight gain. Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. Given that sleep restriction is largely voluntary and potentially correctable, understanding the mechanisms that link insufficient sleep to positive energy balance and the development of obesity, particularly visceral obesity, is crucial to clinical applications, public health policy, and informing future studies. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators will combine energy balance, biomarker, and imaging data with state-of-the art sleep monitoring to provide unambiguous data on the effects of sleep restriction on obesity. Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of obesity, and suggest strategies to reduce this risk.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18-40 years
  • BMI of 18.5-30 kg/m2
  • Not a current smoker or tobacco user
  • No chronic medical or psychiatric disorders
  • On no prescription medications other than second generation antihistamines (cetirizine, fexofenadine, desloratadine, loratadine, etc), oral contraceptive pills, or intrauterine devices
  • History of normal sleep patterns, defined as nocturnal sleep duration of 6.5-8 hours per night without regular daytime naps

Exclusion Criteria:

  • The investigators will exclude subjects who have any medical or psychiatric disorders
  • History of anxiety or depression
  • Those taking any medications other than non-sedating antihistamines or oral contraceptives will be excluded
  • Those found to have depression on a depression screening tool (BDI-II) will be excluded
  • Current smokers will be excluded
  • All female subjects will undergoing a screening pregnancy test and excluded if positive
  • Subjects found to have significant sleep disorders will be excluded

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sleep restriction
Adfærdsmæssigt: Sleep restriction
14 days of sleep restriction, 4 hours of sleep per day.
Ingen indgriben: Normal sleep

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in caloric intake and hunger
Tidsramme: baseline to 21 days
Change in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.
baseline to 21 days
Change in energy expenditure
Tidsramme: baseline to 21 days
Change in energy expenditure, including activity energy expenditure, thermic effect of food (TEF), and basal metabolic rate (BMR), measured during acclimation, experimental and recovery timepoints..
baseline to 21 days
Change in fat tissue characteristics and body composition
Tidsramme: baseline to 21 days
Changes in fat tissue characteristics from serial fat biopsies, and in body composition from DEXA and CT imaging, measured during acclimation, experimental and recovery timepoints.
baseline to 21 days
Change in metabolic hormones
Tidsramme: baseline to 21 days
Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.
baseline to 21 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in neurocognitive deficits
Tidsramme: baseline to 21 days
Change in neurocognitive function measured by battery, measured during acclimation, experimental and recovery timepoints..
baseline to 21 days
Change in blood pressure and autonomic function
Tidsramme: baseline to 21 days
Change in mean arterial blood pressure and autonomic function, measured during acclimation, experimental and recovery timepoints.
baseline to 21 days
Change in markers of inflammation and endothelial function
Tidsramme: baseline to 21 days
Change in markers of inflammation and endothelial function, measured during acclimation, experimental and recovery timepoints.
baseline to 21 days
Change in electrocardiographic characteristics
Tidsramme: baseline to 21 days
Change in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.
baseline to 21 days
Change in arterial stiffness
Tidsramme: baseline to 21 days
Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.
baseline to 21 days
Change in cardiovascular reactivity
Tidsramme: baseline to 21 days
Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.
baseline to 21 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2012

Primær færdiggørelse (Faktiske)

1. maj 2018

Studieafslutning (Faktiske)

1. maj 2018

Datoer for studieregistrering

Først indsendt

17. april 2012

Først indsendt, der opfyldte QC-kriterier

17. april 2012

Først opslået (Skøn)

19. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11-007272

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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