The Natriuretic Peptide Response to Saline Infusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in circulating levels of proBNP 1-108 from baseline to 6 hours
研究概览
简要总结
The primary objective is to evaluate the overarching hypothesis that obese and black individuals have relatively lower circulating natriuretic peptide levels compared with lean and white individuals. Conventional clinical assays for measurement of circulating natriuretic peptides display substantial overlap, precluding determination of the basis of the relative natriuretic peptide deficiency previously observed in these groups. We will study lean or obese, black or white, healthy adult subjects with intravenous (IV) saline infusion as a stimulus for natriuretic peptide production and release. We will measure circulating levels of natriuretic peptide isoforms using mass spectrometry that allows the specific identification of proBNP 1-108 and its cleavage product BNP 1-32.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years;
- •BMI between 18 and 25 (lean) or 30 and 40 kg/m2 (obese);
- •self-reported race of either black or white;
- •otherwise healthy with no chronic comorbidities.
排除标准
- •History of diabetes mellitus
- •Currently pregnant
- •History of cardiac disorder including heart failure, cardiomyopathy, myocardial infarction, coronary revascularization, abnormal stress test, uncontrolled arrhythmia or arrhythmia requiring treatment, congenital heart disease, pericardial disease.
- •History of hypertension defined as taking anti-hypertensive medications or untreated hypertension with systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg at most recent clinical visit or screening visit.
- •Obstructive lung disease
- •History of chronic kidney disease
- •History of liver disease or cirrhosis
- •Uncontrolled thyroid dysfunction
- •History of solid organ transplant
- •History of malignancy other than basal or squamous cell skin cancer
- •Inability to lie flat for 6 hours
研究组 & 干预措施
Saline
Each participant will receive a saline infusion of normal saline 0.9%NaCl
干预措施: Normal Saline 0.9% Infusion Solution Bag (Drug)
结局指标
主要结局
Change in circulating levels of proBNP 1-108 from baseline to 6 hours
时间窗: Saline infusion will be given for 2 hours (with 4 hour observation) with blood samples collected at hourly intervals for 7 hours total
proBNP 1-108 is a protein made by the heart. The change in circulating levels will be measured in response to saline infusion
Change in circulating levels of proBNP 1-32 from baseline to 6 hours
时间窗: Saline infusion will be given for 2 hours (with 4 hour observation) with blood samples collected at hourly intervals for 7 hours total
BNP 1-32 is a hormone made by the heart. The change in circulating levels will be measured in response to saline infusion
次要结局
未报告次要终点
研究者
Deepak Gupta
Assistant Professor of Medicine
Vanderbilt University Medical Center