Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin (PINK)
25 апреля 2017 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
116
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
New York
-
Rochester, New York, Соединенные Штаты, 14642
- University of Rochester Medical Center
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 75 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Женский
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Atorvastatin
44 women randomized to 80 mg atorvastatin for 6weeks
|
80 мг
Другие имена:
|
|
Плацебо Компаратор: sugar pill
44 women randomized to placebo for 6 weeks
|
80mg
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean Low Density Lipoprotein Cholesterol in Blood
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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 Waist Circumference
Временное ограничение: 6 weeks
|
Waist circumference was measured with a ruler tape.
|
6 weeks
|
|
Mean Systolic Blood Pressure
Временное ограничение: 6 weeks
|
Measured with a blood pressure cuff
|
6 weeks
|
|
Mean Diastolic Blood Pressure
Временное ограничение: 6 weeks
|
Measured with a blood pressure cuff
|
6 weeks
|
|
Mean High Density Lipoprotein Cholesterol in Blood
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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 Vascular Adhesion Molecule in Blood
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean Waist Circumference
Временное ограничение: week 0
|
Waist circumference was measured with a ruler tape.
|
week 0
|
|
Mean Low Density Lipoprotein Cholesterol in Blood
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 0 weeks
|
Measured with a blood pressure cuff
|
0 weeks
|
|
Mean Diastolic Blood Pressure
Временное ограничение: 0 weeks
|
Measured with a blood pressure cuff
|
0 weeks
|
|
Mean Vascular Adhesion Molecule in Blood
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Gladys P Velarde, MD, University of Rochester
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 ноября 2004 г.
Первичное завершение (Действительный)
1 декабря 2011 г.
Завершение исследования (Действительный)
1 мая 2013 г.
Даты регистрации исследования
Первый отправленный
1 февраля 2013 г.
Впервые представлено, что соответствует критериям контроля качества
4 февраля 2013 г.
Первый опубликованный (Оценивать)
7 февраля 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
7 июня 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
25 апреля 2017 г.
Последняя проверка
1 апреля 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Нарушения метаболизма глюкозы
- Метаболические заболевания
- Болезнь
- Резистентность к инсулину
- Гиперинсулинизм
- Синдром
- Метаболический синдром
- Молекулярные механизмы фармакологического действия
- Ингибиторы ферментов
- Антиметаболиты
- Антихолестеринемические агенты
- Гиполипидемические агенты
- Агенты, регулирующие уровень липидов
- Ингибиторы гидроксиметилглутарил-КоА-редуктазы
- Аторвастатин
Другие идентификационные номера исследования
- Protocol No. 1988
- Grant# 2004-1035 (Другой номер гранта/финансирования: RSRB 29937)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .