- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03398889
Intestinal Microbiome and Extremes of Atherosclerosis
Studieoversikt
Status
Detaljert beskrivelse
Patients were phenotyped by their residual score in linear multiple regression with measured carotid plaque burden as the dependent variable and coronary risk factors were predictors. The residual score essentially represents the distance off the regression line of predicted plaque. They were grouped into three categories: Unexplained atherosclerosis (with more plaque than predicted by risk factors; residual score >2); Explained (the amount of plaque predicted by risk factors, residual score >-2 and <2); and Protected (less plaque than predicted by risk factors, residual score <-2).
DNA was extracted from stool samples in the lab of Dr. Allen-Vercoe at University of Guelph. RNA makeup of the intestinal microbiome was assessed in the lab of Dr. Gregory Gloor at Western. Plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate were measured by ultra-performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry in the lab of Dr. Bradley Urquhart at Western.
Nutrient intake over the past year was calculated at the Harvard School of Public Health from the 131 item self-reported and semi-quantitative Harvard Food Frequency Questionnaire (FFQ).
Estimated glomerular filtration rate was calculated from the Chronic Kidney Disease Epidemiological (CKD-EPI) equations.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
London, Ontario, Canada, N6G 2V4
- Stroke Prevention & Atherosclerosis Research Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients attending stroke prevention clinics and a Premature Atherosclerosis Clinic at University Hospital, London, ON, Canada,
- with measurements of carotid plaque burden and the risk factors used in the linear regression model.
- Willing to consent to the protocol approved by the Ethics board
Exclusion Criteria:
- Missing data on variables used in the regression model,
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Unexplained Atherosclerosis phenotype
Residual score in linear regression >2
|
plasma levels of metabolites
Harvard food frequency questionnaire
amplification and sequencing of 16S rRNA gene variable regions in stool samples
|
Explained Atherosclerosis phenotype
Residual score in linear regression <-2, <2
|
plasma levels of metabolites
Harvard food frequency questionnaire
amplification and sequencing of 16S rRNA gene variable regions in stool samples
|
Protected Atherosclerosis phenotype
Residual score <-2
|
plasma levels of metabolites
Harvard food frequency questionnaire
amplification and sequencing of 16S rRNA gene variable regions in stool samples
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Plasma levels of metabolites in the three phenotypes
Tidsramme: Day 1
|
Plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate
|
Day 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Bacterial profile of the intestinal microbiome
Tidsramme: Day 1
|
Amplification and sequencing of 16S rRNA gene variable regions
|
Day 1
|
Effect of nutrient intake on plasma levels of metabolites
Tidsramme: Day 1
|
Nutrient analysis from food frequency questionnaire
|
Day 1
|
Effect of renal function on plasma levels of metabolites
Tidsramme: Day 1
|
eGFR from CKD-EPI equations
|
Day 1
|
Samarbeidspartnere og etterforskere
Sponsor
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 105166
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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