Effects of Pioglitazone on Platelet Function (UHEM08014)
2015年12月23日 更新者：Charles Francis、University of Rochester
The purpose of this study is to determine how pioglitazone and aspirin affect platelets in the blood of diabetic and non-diabetic subjects.
Platelets are small cells in the blood that help with blood clotting.
Pioglitazone is a drug that is used to lower blood sugar and fats by helping the body to use insulin correctly.
Pioglitazone is presently used to treat diabetes but has not been approved for non-diabetics.
This study will determine whether pioglitazone reduces the activity of platelets in people who are or are not also taking aspirin.
研究概览
详细说明
Blood samples will be taken at time 0 to measure platelet aggregation.
30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation.
After 6-9 days, subjects will ingest 81mg of aspirin.
Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin.
Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
研究类型
介入性
注册 (实际的)
40
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
Rochester、New York、美国、14642
- University of Rochester
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects must be over 21 years of age and provide written informed consent.
- Normal subjects must have a BMI <30 and must not have known cardiovascular disease, Diabetes Mellitus (DM), hyperlipidemia, or hypertension. Diabetic subjects must have previously diagnosed DM.
Exclusion Criteria:
- Subjects will be excluded if they have hypersensitivity to aspirin or pioglitazone, or if they are receiving warfarin or heparin therapy, are pregnant, or have congestive heart failure or hepatic function impairment.
- Subjects must not have taken aspirin or other drugs inhibiting platelet function such as Plavix or non-steroidal anti-inflammatory drugs for 7 days.
- Subjects will be excluded if they have a history of renal failure, severe liver disease, myeloproliferative disease or other conditions that impair platelet function.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Pioglitazone with or without Aspirin
Blood samples will be taken at time 0 to measure platelet aggregation.
30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation.
After 6-9 days, subjects will ingest 81mg of aspirin.
Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin.
Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
|
81 毫克
30mg Pioglitazone x1
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent Platelet Aggregation Induced by Arachidonic Acid
大体时间：at baseline and days 6-9
|
Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6.
Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release.
Aggregation was initiated using arachidonic acid (0.5 mM).
At each time point the results are shown for maximum percent aggregation with arachidonic acid for all subjects.
Sample 1 was obtained at baseline (BL).
Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone.
Sample 3 was obtained 6-9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.
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at baseline and days 6-9
|
|
Percent Platelet Aggregation Induced by Collagen
大体时间：baseline and day 6-9
|
Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6.
Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release.
Aggregation was initiated using collagen (2ug.mL).
At each time point the results are shown for maximum percent aggregation with collagen for all subjects.
Sample 1 was obtained at baseline (BL).
Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone.
Sample 3 was obtained 6-9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.
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baseline and day 6-9
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Charles W Francis, MD、University of Rochester
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年12月1日
初级完成 (实际的)
2010年6月1日
研究完成 (实际的)
2011年6月1日
研究注册日期
首次提交
2009年3月9日
首先提交符合 QC 标准的
2009年3月12日
首次发布 (估计)
2009年3月13日
研究记录更新
最后更新发布 (估计)
2016年2月3日
上次提交的符合 QC 标准的更新
2015年12月23日
最后验证
2015年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.