Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin (PINK)
2017년 4월 25일 업데이트: Gladys Velarde, University of Rochester
Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin
Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood.
The purpose of this study is two fold;
- To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS.
- To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.
연구 개요
상세 설명
The first phase of the study is an observational phase as previously described.
The second phase was a prospective evaluation of the effect of a well known "statin" drug (Lipitor) on different biochemical factors measured in the blood.
The eligible study participants had blood work done upon enrollment and if criteria was met(according to the Adult Treatment Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1 diet) as a lead in phase.
Lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for MBS,randomization for either atorvastatin (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.
연구 유형
중재적
등록 (실제)
116
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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Rochester, New York, 미국, 14642
- University of Rochester Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
Inclusion Criteria:
- Women between the ages of 18-75 with Metabolic syndrome
- Abdominal circumference > 35 in
- Hypertriglyceridemia > 150mg/dl
- HDL <50
- Blood Pressure >130/85
- Fasting Glucose >100
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next 6-12 months
- Receiving lipid-lowing drugs
- Obstructive hepatobiliary disease or serious hepatic disease
- Diabetes, cardiovascular disease (CVD), hypothyroidism, active infection, cancer, recent surgery
- Fulfill criteria to receive statin based on LDL levels, risk factors, and Framingham risk scoring outlined on ATP111/NCEP 111 recommendations
- Documented allergic reaction to statin in past
- unexplained elevation in creatinine kinase levels > 3 times upper limit
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Atorvastatin
44 women randomized to 80 mg atorvastatin for 6weeks
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80mg
다른 이름들:
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위약 비교기: sugar pill
44 women randomized to placebo for 6 weeks
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80mg
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Low Density Lipoprotein Cholesterol in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Triglycerides in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Apolipoprotein B in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
The ratio of Apo B to Apo A1 ratio was calculated.
|
6 weeks
|
|
Mean High Sensitivity C-reactive Protein in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
The ratio of Apo B to Apo A1 ratio was calculated
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6 weeks
|
|
Mean Waist Circumference
기간: 6 weeks
|
Waist circumference was measured with a ruler tape.
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6 weeks
|
|
Mean Systolic Blood Pressure
기간: 6 weeks
|
Measured with a blood pressure cuff
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6 weeks
|
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Mean Diastolic Blood Pressure
기간: 6 weeks
|
Measured with a blood pressure cuff
|
6 weeks
|
|
Mean High Density Lipoprotein Cholesterol in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Fasting Plasma Glucose in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Aspartate Aminotransferase in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Alanine Aminotransferase in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Leptin in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Soluble Intercellular Adhesion Molecule in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
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Mean Soluble Vascular Adhesion Molecule in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Plasminogen Activator Inhibitor-1 in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
6 weeks
|
|
Mean Myeloperoxidase in Blood
기간: 6 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
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6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Waist Circumference
기간: week 0
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Waist circumference was measured with a ruler tape.
|
week 0
|
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Mean Low Density Lipoprotein Cholesterol in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Triglycerides in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Myeloperoxidase in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Fasting Blood Glucose in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean High Density Lipoprotein Cholesterol in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Intercellular Adhesion Molecule in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Systolic Blood Pressure
기간: 0 weeks
|
Measured with a blood pressure cuff
|
0 weeks
|
|
Mean Diastolic Blood Pressure
기간: 0 weeks
|
Measured with a blood pressure cuff
|
0 weeks
|
|
Mean Vascular Adhesion Molecule in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Apolipoprotein A-1 in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Apolipoprotein B in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
The ratio of Apo B to Apo A1 ratio was calculated.
|
0 weeks
|
|
Mean Hs-C Reactive Protein in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Leptin in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
|
Mean Plasminogen Activator Inhibitor-1 in Blood
기간: 0 weeks
|
Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit.
Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation.
Each sample was sent to the University of Rochester Clinical Laboratories for testing.
|
0 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2004년 11월 1일
기본 완료 (실제)
2011년 12월 1일
연구 완료 (실제)
2013년 5월 1일
연구 등록 날짜
최초 제출
2013년 2월 1일
QC 기준을 충족하는 최초 제출
2013년 2월 4일
처음 게시됨 (추정)
2013년 2월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 6월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 4월 25일
마지막으로 확인됨
2017년 4월 1일
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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Kumamoto University완전한
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CHU de Quebec-Universite LavalCanadian Institutes of Health Research (CIHR); Biovalorem모병
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Liaoning University of Traditional Chinese MedicineMinistry of Science and Technology of the People´s Republic of China완전한