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临床试验/NCT03834168
NCT03834168已完成不适用

The Diurnal Rhythm in Natriuretic Peptide Levels and Relationship With Nocturnal Blood Pressure

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Plasma MRproANP

研究概览

简要总结

The purpose of the study to assess the diurnal rhythm in natriuretic peptide levels and its temporal relationship with nocturnal blood pressure in obese and African-American individuals as compared with lean and white individuals.

详细描述

Obese and African-American individuals are at greater risk for cardiovascular morbidity and mortality than lean and white individuals. One of the key reasons for this health disparity is a higher risk of hypertension among obese and African-American individuals. The reasons for why these disparities develop are not well understood.

Natriuretic peptides are hormones produced by the heart and have a wide range of favorable cardiovascular effects such as natriuresis (sodium excretion), vasodilation, and direct inhibition of the renin-angiotensin-aldosterone system. Human studies showed the existence of 24-hour (diurnal) variations in the circulating natriuretic peptide levels.

Prior work from the investigators and others demonstrated that individuals with genetically-determined lower circulating natriuretic peptides levels have higher blood pressure and greater risk of hypertension. Further, the investigators have shown that obesity and African-American race are associated with lower natriuretic peptide levels, suggesting that relatively low natriuretic peptide levels may be a biologic determinant contributing to health disparities.

Obese and African-American individuals have a greater prevalence of nocturnal hypertension [nighttime blood pressure >120/80 mmHg], which is an independent risk factor for cardiovascular events. The underlying reasons for 24-hour variations in blood pressure are unknown.

The investigators hypothesize that loss of the natural 24-hour rhythm of natriuretic peptide levels plays a role in the development of nocturnal hypertension in obese and African-American individuals. The aims of this study are:

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 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 18 to 40 years
  • Blood pressure less than 140/90
  • Body Mass Index between 18.5 to 25 kg/m2 (lean) or 30 to 45 kg/m2 (obese)
  • Self identified African-American or white individuals
  • Willingness to comply with the study diet
  • Provide informed consent

排除标准

  • History of hypertension
  • History of cardiovascular, renal, or liver disease
  • Diabetes or use of glucose-lowering medications
  • Use of vasoactive or diuretic medications
  • Atrial fibrillation
  • Anemia (Hematocrit <41%)
  • Abnormal serum sodium or potassium
  • Abnormal liver function tests (>3x upper limit of normal)
  • Current smokers
  • Regular users of non-steroid anti-inflammatory medications

结局指标

主要结局

Plasma MRproANP

时间窗: About 24 hours on the in-patient study visit day after consuming study meals for 5 days

Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals

次要结局

  • Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm(About 24 hours on the in-patient study visit day after consuming study meals for 5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pankaj Arora, MD

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

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