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临床试验/NCT03934255
NCT03934255已完成不适用

Central and Peripheral Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年1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
32
试验地点
2
主要终点
Core body temperature amplitude

研究概览

简要总结

This study seeks to examine central and peripheral circadian mechanisms in Blacks with appropriately dipping systolic blood pressure (blood pressure that dips by at least 10%) compared with non-dipping systolic blood pressure (blood pressure that dips by less than 10%) using a constant routine protocol. Constant routine protocols are commonly used in the field of circadian biology to examine rhythms in biological processes while controlling the entraining effects of light, activity, and diet.

详细描述

This study will enroll a total of 40 participants (n=20 non-dippers; n=20 dippers) to complete a 30-hour constant routine protocol. Participants will undergo baseline testing that includes anthropometric measurements, clinic blood pressure measurements, completion of self-report questionnaires on sleep and mood, be fitted with an ambulatory blood pressure monitor and actigraphy watch, and be provided with home sleep testing (HST) equipment.

Following completion of baseline assessment, eligible participants will be scheduled for the 30-hour constant routine protocol. The 30-hour constant routine protocol will allow for the hourly collection of saliva, collection of buccal cells every 4 hours, and constant monitoring of core body temperature, all of which are primary outcomes in the assessment of central and peripheral circadian clock markers. Amplitude and phase of these outcomes will be assessed in non-dippers versus dippers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Black or African American race
  • Age 18 years or older

排除标准

  • Work alternating or night shifts
  • Pregnant or nursing
  • Current illicit drug use
  • History of severe mental illness
  • Medical conditions that would be contraindicated for a constant routine protocol
  • Take anti-hypertensive medications or beta-blockers
  • Severe obstructive sleep apnea

结局指标

主要结局

Core body temperature amplitude

时间窗: Core body temperature amplitude during a 30-hour constant routine protocol

Circadian amplitude of core body temperature recorded and transmitted wirelessly

Melatonin phase

时间窗: Melatonin phase during a 30-hour constant routine protocol

Circadian phase of melatonin obtained from saliva

Melatonin amplitude

时间窗: Melatonin amplitude during a 30-hour constant routine protocol

Circadian amplitude of melatonin obtained from saliva

Core body temperature phase

时间窗: Core body temperature phase during a 30-hour constant routine protocol

Circadian phase of core body temperature recorded and transmitted wirelessly

Buccal cell mRNA expression

时间窗: Expression of Bmal1 and Period 3 during a 30-hour constant routine protocol

Expression of Bmal1 and Period 3 obtained from buccal cell mRNA

次要结局

  • Cortisol phase(Cortisol phase during a 30-hour constant routine protocol)
  • Cortisol amplitude(Cortisol amplitude during a 30-hour constant routine protocol)

研究者

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

Stephen Justin Thomas, PhD

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

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