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Impact of Exenatide on Sleep in Type 2 Diabetes

16. august 2018 opdateret af: University of Chicago

Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study

The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

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
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
      • Chicago, Illinois, Forenede Stater, 60637
        • The University of Chicago

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

Exclusion Criteria:

  • Patients with unstable cardiac, neurological or psychiatric disease
  • Women who are pregnant or report trying to get pregnant will be excluded.
  • Patients treated for obstructive sleep apnea (OSA) will be excluded.
  • Patients with established OSA will be included only if they have declined treatment of OSA.
  • Patients with morbid obesity (BMI ≥ 40 gk/m2)
  • Patients on insulin
  • Patients already taking an incretin-based drug will not be included
  • Patients with renal disease (creatinine clearance <30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
  • Patients taking an insulin secretagogue will be excluded.
  • Patients with Hemoglobin A1c values greater than or equal to 10 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: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Usual T2 DM med regimen
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Medicin: Placebo
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
Eksperimentel: Usual T2 DM med regimen plus Exenatide
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Medicin: Exenatide
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-REM Slow Wave Sleep
Tidsramme: baseline and after 6 weeks of treatment
Total minutes of non-REM sleep was measured
baseline and after 6 weeks of treatment
Total Amount of Slow Wave Activity
Tidsramme: baseline and after 6 weeks of treatment
Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured
baseline and after 6 weeks of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep Efficiency During Polysomnographic Recording
Tidsramme: baseline and after 6 weeks of treatment
Sleep efficiency will be calculated as total sleep time over total recording time.
baseline and after 6 weeks of treatment
Minutes of Wake After Sleep Onset During Sleep Recording
Tidsramme: baseline and after 6 weeks of treatment
total amount of time spent awake after sleep onset and before morning awakening will be calculated
baseline and after 6 weeks of treatment
Severity of Obstructive Sleep Apnea
Tidsramme: baseline and after 6 weeks of treatment
The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea.
baseline and after 6 weeks of treatment
Mean 24-h Blood Glucose Levels
Tidsramme: baseline and after 6 weeks of treatment
Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.
baseline and after 6 weeks of treatment

Samarbejdspartnere og efterforskere

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

Sponsor

University of Chicago

Efterforskere

  • Ledende efterforsker: Eve Van Cauter, PhD, University of Chicago

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 (Faktiske)

1. juni 2010

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

13. april 2010

Først indsendt, der opfyldte QC-kriterier

2. juni 2010

Først opslået (Skøn)

3. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09-291-B

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Georgia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner