- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03398889
Intestinal Microbiome and Extremes of Atherosclerosis
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ontario
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London, Ontario, 캐나다, N6G 2V4
- Stroke Prevention & Atherosclerosis Research Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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,
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Unexplained Atherosclerosis phenotype
Residual score in linear regression >2
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plasma levels of metabolites
Harvard food frequency questionnaire
amplification and sequencing of 16S rRNA gene variable regions in stool samples
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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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Plasma levels of metabolites in the three phenotypes
기간: Day 1
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Plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate
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Day 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Bacterial profile of the intestinal microbiome
기간: Day 1
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Amplification and sequencing of 16S rRNA gene variable regions
|
Day 1
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Effect of nutrient intake on plasma levels of metabolites
기간: Day 1
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Nutrient analysis from food frequency questionnaire
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Day 1
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Effect of renal function on plasma levels of metabolites
기간: Day 1
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eGFR from CKD-EPI equations
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Day 1
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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