Diagnosing Natriuretic Peptide Deficiency
Diagnosing Natriuretic Peptide Deficiency: A Pilot Study
In this pilot study, the investigators will determine the response of the natriuretic peptide (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The goal of the proposed project is to generate preliminary data that will be used to develop power calculations, inform cutoff ranges, and inform the timing of the NP response for larger subsequent studies.
Aim: To determine the range of distribution and time course of natriuretic peptide (NP) responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.
Hypothesis: Determination of the NP responses (the range and time course of changes in NP levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency of blood sampling in a definitive prospective study, as well as enable investigators to perform a sample size calculation for a definitive prospective study.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Tennessee
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Nashville、Tennessee、美国、37203
- Vanderbilt University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- Men and women ages 18-50 years
- BMI 18.5 to <25 kg/m^2
Exclusion Criteria:
- Significant use of systemically-absorbed glucocorticoids currently or for an extended period of time during the prior 6 months
- Current use of antihypertensive medications
- Current use of metformin, or any antidiabetic medications (which could affect glucose and insulin levels)
- Current use of medications known to affect dexamethasone metabolism, including phenytoin, rifampin, carbamazepine, troglitazone, and barbiturates
- Active, clinically significant infection at time of visit
- History of adrenal insufficiency or Cushing's syndrome
- Prior or current cardiovascular disease, renal disease, or liver disease
- Diabetes mellitus, pre-diabetes, impaired fasting glucose, or impaired glucose tolerance
- Atrial fibrillation
- Bleeding disorder or anemia
- Elevated Liver Functions Tests > 2 times upper limit of normal
- Estimated glomerular filtration rate < 60 ml/min
- HbA1c > 5.7
- Abnormal sodium or potassium level
- Positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding
学习计划
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：Healthy
10 Healthy subjects will undergo study procedures at four study visits. All subjects will undergo the same procedures and interventions. |
A single dose of dexamethasone IV 4 mg will be administered.
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 |
|---|---|---|
|
Changes in NT-proANP From Baseline to 8 Hours
大体时间：baseline and 8 hours
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Change in natriuretic peptide levels after drug administration
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baseline and 8 hours
|
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Changes in NT-proBNP From Baseline to 8 Hours
大体时间：Baseline and 8 hours
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Change in natriuretic peptide levels after drug administration
|
Baseline and 8 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in NT-proANP
大体时间：baseline, 24 hours, 48 hours and 72 hours
|
Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
|
baseline, 24 hours, 48 hours and 72 hours
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Changes in NT-proBNP
大体时间：at baseline, 24 hours, 48 hours and 72 hours
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Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
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at baseline, 24 hours, 48 hours and 72 hours
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BNP (B-type Natriuretic Peptide)
大体时间：0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
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Natriuretic peptide levels after drug administration
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0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
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ANP (Atrial Natriuretic Peptide)
大体时间：0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
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Natriuretic peptide levels after drug administration
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0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
|
合作者和调查者
调查人员
- 首席研究员：Katherine N Bachmann, MD、Vanderbilt Endocrinology
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.