Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study
2018年3月30日 更新者：University of Florida
The purpose of this study is to determine if, in a subset of patients treated with a beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour oral glucose tolerance test (OGTT) compared to fasting glucose measurement.
研究概览
详细说明
Beta-blockers and diuretics have a well-established role in treating hypertension and are frequently used first-line.
However, it is increasingly evident that these medications have harmful metabolic effects.
The Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR - NCT00246519) study was a greater than 700 participant, randomized, parallel assignment trial, aimed at determining the genetic factors that influence response to both a beta-blocker (atenolol) and a diuretic (hydrochlorothiazide [HCTZ]).
The PEAR trial design includes evaluation at baseline, after monotherapy with either medication, and after combination therapy with both medications.
This pilot, PEAR sub-study aims to characterize the ability of two diagnostics tests (fasting glucose versus glucose 2-hours after an OGTT) to detect prediabetes development prior to blood pressure medication use, after monotherapy (with atenolol or HCTZ) and after combination therapy (with atenolol and HCTZ).
研究类型
观察性的
注册 (实际的)
26
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
-
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Florida
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Gainesville、Florida、美国、32610
- University of Florida Department of Community Health and Family Medicine
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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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Primary care clinic, PEAR participants
描述
Inclusion Criteria:
participation in PEAR:
- an average seated home DBP > 85 mmHg and home SBP < 180 mmHg.
- subjects must also have an average seated (> 5 minutes) clinic DBP between 90 mmHg and 110 mmHg and SBP < 180 mmHg.
Exclusion Criteria:
- secondary forms of HTN,
- patients currently treated with three or more antihypertensive drugs, isolated systolic HTN,
- other diseases requiring treatment with BP lowering medications,
- heart rate < 55 beats/min,
- known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and TIA),
- diabetes mellitus (Type 1 or 2),
- renal insufficiency (serum creatinine > 1.5 in men or 1.4 in women),
- primary renal disease,
- pregnancy or lactation,
- liver enzymes > 2.5 upper limits of normal,
- current treatment with NSAIDS,
- COX2-inhibitors,
- oral contraceptives or estrogen.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
PEAR Participants
All participants eligible for PEAR study.
Each participant will be have fasting and oral glucose tolerance test data collected.
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For assessment of dysglycemia, 75 grams of glucose solution by mouth at 3 PEAR study visits for all enrolled participants: baseline, single drug therapy assessment, and dual drug therapy assessment.
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 |
|---|---|---|
|
Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment
大体时间：Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)
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A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points.
At each of these time points the two methods for evaluating prediabetes were compared.
Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.
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Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)
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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。
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
2009年5月1日
初级完成 (实际的)
2010年12月1日
研究完成 (实际的)
2010年12月1日
研究注册日期
首次提交
2010年4月1日
首先提交符合 QC 标准的
2010年4月6日
首次发布 (估计)
2010年4月7日
研究记录更新
最后更新发布 (实际的)
2018年4月3日
上次提交的符合 QC 标准的更新
2018年3月30日
最后验证
2018年3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.