Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participant is a Caucasian (including Hispanic) male
- Participant has a maximum waist size of 40 inches
- Participant does not currently use any lipid-altering medications
- Participant is in good health other than the diagnosis of dyslipidemia
Exclusion Criteria:
- Participant has had stomach ulcers within the last 3 months
- Participant has had a heart attack in the last 6 months or has angina
- Participant has chronic heart failure
- Participant has a history of stroke, seizures, or major neurological disorder
- Participant has a history of cancer
- Participant has a gastrointestinal condition that affects bowel movements
- Participant has type 1 or 2 diabetes
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Simvastatin 40 mg first, then placebo
Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks
|
40 mg once daily for 2 weeks
다른 이름들:
Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
|
|
위약 비교기: Placebo first, then simvastatin 40 mg once daily
Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks
|
40 mg once daily for 2 weeks
다른 이름들:
Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Arachidonic Acid Level After 2 Weeks of Treatment
기간: 2 weeks
|
Arachidonic acid level (20:4n6) in the cholesterol ester lipid class. The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term. |
2 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fasting Blood Lipidomic Levels After 2 Weeks of Treatment
기간: 2 weeks
|
Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo. The mean reported was an adjusted mean. |
2 weeks
|
|
Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level
기간: 2 weeks
|
Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio [dose = 162 g/m^2]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion. The mean reported was an adjusted mean (defined in first outcome measure). |
2 weeks
|
|
Blood Linoleic Acid Levels
기간: 2 weeks
|
Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.
|
2 weeks
|
|
Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo
기간: 2 weeks
|
Change in fasting delta 5 desaturase enzyme activity compared to placebo.
Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.
|
2 weeks
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0000-140
- 2009_609
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Simvastatin에 대한 임상 시험
-
Enrique de-MadariaFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana 그리고 다른 협력자들종료됨