T-helper 2 (Th2) Cytokine Responses in Overweight/Obese Subjects
2014年3月11日 更新者：David Skoner, MD、West Penn Allegheny Health System
Th2 Cytokine Responses in Overweight/Obese Subjects
Cytokines are chemicals that are naturally made by your body.
Certain cytokine levels are changed in the blood of patients who develop allergies and/or asthma.
Cytokine levels may also be changed in some individuals who are overweight or obese.
The purpose of this study is to determine if certain cytokine levels differ based on a person's weight and whether or not they have allergies or asthma.
Information gathered in this study will be compared to information gathered from subjects who have participated in another similar study for patients who have allergies and/or asthma.
研究概览
详细说明
The aims of this study are to:
- Characterize the relationship between BMI and Th2 skewing in non-atopic adult subjects.
- Compare these results to those previously obtained from atopic adult subjects It is expected that the results of this study will demonstrate enhanced Th2 skewing in overweight and obese atopic subjects as compared to non-atopic subjects. It is further anticipated that the results of this study will be used as preliminary data to generate an NIH grant application exploring the link between obesity and atopy.
研究类型
观察性的
注册 (实际的)
46
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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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny General Hospital, Dept. of Allergy, Asthma, & Immunology
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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 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Subjects will be male or female, aged 18-50 years, and of any race.
Subjects must be healthy with no history of allergies or asthma.
Subjects will be placed in one of three groups based on their BMI: normal, overweight, or obese.
描述
Inclusion Criteria:
- adults aged 18 to 50 years
- pre-bronchodilator FEV1 > 80% predicted with no evidence of reversibility following administration of bronchodilator
- no history of allergies
Exclusion Criteria:
- medical history consistent with atopy and/or asthma
- any positive response to allergy skin testing for inhalant allergens (defined as a wheal > 3 mm larger than the negative control)
- a pre-bronchodilator FEV1 < 80% predicted
- > 12% reversibility in FEV1 following administration of a bronchodilator
- any history of significant chronic illness
- history of respiratory infection within the past 2 weeks
- any use of prescription medications other than oral contraceptives or thyroid hormone replacement within the past 2 months
- use of any investigational medication within the past month
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 |
|---|
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Normal BMI
Subjects with a BMI range of 18.5 to 24.9 which is defined by the CDC as within normal range.
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Overweight BMI
Subjects with a BMI of 25.0 to 29.9 are defined by the CDC as being overweight.
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Obese BMI
Subjects with a BMI of 30.0 and above are defined by the CDC as being obese.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Th2 Cytokine levels
大体时间：Baseline (only visit)
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Baseline (only visit)
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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：David Skoner, MD、Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- 研究主任：Deborah Gentile, MD、Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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
研究注册日期
首次提交
2009年5月28日
首先提交符合 QC 标准的
2014年3月11日
首次发布 (估计)
2014年3月13日
研究记录更新
最后更新发布 (估计)
2014年3月13日
上次提交的符合 QC 标准的更新
2014年3月11日
最后验证
2014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.