- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02130050
Metabolic Profiling in Patients With Obstructive Sleep Apnea: From Plasma to Hypoxic Cell Model of Peripheral Monocyte
30. april 2014 opdateret af: National Taiwan University Hospital
This three-year project aims to
- Profile the differentially expressed metabolites in healthy patients with severe Obstructive sleep apnea (OSA) before and after six-month continuous positive airway pressure (CPAP) treatment
- Identify the candidate metabolites involved in biologic pathways attributing to OSA phenotyping and response to CPAP treatment
- Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Obstructive sleep apnea is characterized with chronic intermittent hypoxia and sleep fragmentations.
The sequels of OSA included excessive daytime sleepiness, cardiovascular disease, and neurocognitive dysfunction which could be reversed with continuous positive airway pressure (CPAP).
A couple of biologic pathways have been associated with the phenotyping of OSA which included craniofacial morphology, ventilator control, body fat distribution/metabolism, and sleepiness vulnerability.
Metabolomics, a recently developed technique to detect metabolomic profiles, could help to understand the disease pathophysiology and explore biomarkers.
So far, only one paper studied the metabolomic profile in patients with OSA where putative identifications of 14 statistically significant features were profiled.
Our pilot study comparing the metabolic profiling in OSA patients randomly assigned to therapeutic and subtherapeutic CPAP showed CPAP treatment did alter the metabolomic profile.
Seventeen metabolites in three biologic pathways and 13 metabolites in the six biologic pathways were identified in therapeutic and subtherapeutic CPAP, respectively.
Sixteen metabolites in three biologic pathways were identified by comparing two groups.
However, there were a couple of weakness in studies in the literature and ours.
Furthermore, the direct causal relationship of the profiled metabolites and OSA needs to be clarified.
Therefore, we plan to compare the metabolic profiling in control subjects and healthy OSA patients, before and after six-month CPAP treatment, to identify candidate metabolites involved in biologic pathways attributing to phenotyping and response to CPAP treatment.
Furthermore, candidate metabolites involved in biologic pathways, especially pathways of ROS, inflammation, and metabolism, will be validated in the intermittent hypoxia model of peripheral monocytes.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
24
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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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
20 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
moderate to severe OSA from primary care clinic friends and families from recommendation of OSA patients
Beskrivelse
OSA patients
Inclusion Criteria:
- male patients aged 20 to 90 year who have daytime sleepiness (ESS>=10)
- newly diagnosed OSA (AHI>30/hr) by overnight PSG but never been treated
Exclusion Criteria:
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
- active infection two weeks prior to screening
- enrolled in other trials in the study period
- other sleep disorders
- sleepy driver
- using maintenance medications
Control subjects
Inclusion Criteria:
- Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
- non-sleepy
- no OSA confirmed by home sleep study (AHI<5/hr)
Exclusion Criteria:
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
- active infection two weeks prior to screening
- enrolled in other trials in the study period
- other sleep disorders
- using maintenance medications
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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OSA Patient
•male patients aged 30 to 65 yr who are newly diagnosed as severe OSA (AHI >=30/hr)
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Control subjects:
•male control subjects are recruited from Heath Check-up Center.
Subjects who are matched with OSA patients at age (+/-2 yrs), body height (+/-3cm) and body weight (<100 kg: +/-3kg, >100 kg: +/-4kg) are screened.
Only subjects who are not sleepy (ESS<10) and have no OSA (AHI<5/hr PSG)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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The expressed metabolites profiles
Tidsramme: 6 months
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Profiling the differentially expressed metabolites in control subjects and healthy patients with severe OSA before and after six-month CPAP treatment
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Metabolites in the intermittent-hypoxia model of peripheral monocytes
Tidsramme: 6 months
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Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Peilin Lee, M.D., National Taiwan University Hospital
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. april 2014
Primær færdiggørelse (Forventet)
1. april 2015
Studieafslutning (Forventet)
1. april 2015
Datoer for studieregistrering
Først indsendt
11. april 2014
Først indsendt, der opfyldte QC-kriterier
30. april 2014
Først opslået (Skøn)
2. maj 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201401106RINB
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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