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临床试验/NCT03934398
NCT03934398已完成不适用

Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年4月10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
41
试验地点
1
主要终点
Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)

研究概览

简要总结

The investigators aim to determine the association of dietary intake on cardiovascular disease risk factors among children with overweight and obesity who are being evaluated for elevated blood pressure.

The investigators will also investigate for predictors of vascular function and determine if predictors vary by level of sodium intake.

详细描述

This research is being done to determine if the food or salt eaten can cause arteries to be stiffer and/or not work as well and if it can impact blood pressure over a 24-hour period of time. The investigators also want to determine if there are any risk factors or blood tests that can predict how stiff arteries are or how well arteries function. The investigators hope that the information from this study will help the investigators prevent blood pressure-related cardiovascular disease in children. This knowledge could help shape future guidelines on how to best prevent and treat high blood pressure and heart disease in children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
— 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Overweight or obese
  • Elevated blood pressure
  • Referred to the ReNEW Clinic at Johns Hopkins University for evaluation and treatment of elevated blood pressure.

排除标准

  • The only children who will not be eligible for inclusion in this study are those who are non-English speaking.

结局指标

主要结局

Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)

时间窗: 1 day

The Ambulatory Arterial Stiffness Index will be determined from data obtained from vascular measures and during 24-hour ambulatory blood pressure monitoring. Arterial stiffness increases as the regression slope approaches 0 and the AASI approaches 1.

Endothelial function as assessed by Laser Doppler flow perfusion

时间窗: 1 day

The percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.

Mean Blood pressure (mmHg)

时间窗: 1 day

Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.

Arterial stiffness as assessed by Pulse wave velocity

时间窗: 1 day

This will be determined from Pulse wave velocity (m/sec) done at the study visit

Arterial stiffness as assessed by Augmentation Index

时间窗: 1 day

The Augmentation Index (measured as a percentage) will be determined from a vascular assessment and data obtained during 24-hour ambulatory blood pressure monitoring. A greater Augmentation Index represents a stiffer, less compliant vessel.

次要结局

  • Children's Emotion Management Scale (CEMS) score(1 day)
  • Pediatric Adverse Childhood Events (ACEs) score(1 day)
  • Behavior Assessment for Children (BASC) score(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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