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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03560869
Other study ID # 1097747
Secondary ID R01HL1283885P20G
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2017
Est. completion date June 13, 2019

Study information

Verified date January 2021
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition.


Description:

The purpose of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. Additionally, we will determine whether or not the sympathetic nervous system has a role in mediating blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition. This will allow for a within participant comparison. Additionally, we will later determine if age alters blood pressure control at rest or during static exercise.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 13, 2019
Est. primary completion date June 13, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria (Young): • age: 20-35 years old Exclusion Criteria (Young): - high blood pressure (>140/90 mmHg) - history of cardiovascular disease - history of cancer - history of diabetes - history of kidney disease - obesity (BMI > 30 kg/m2) - smoking or tobacco use - current pregnancy - nursing mothers - communication barriers Inclusion Criteria (Older): - age: 60-75 years old - ECG within normal limits - screening blood panel within normal limits Exclusion Criteria (Older): - high blood pressure (>140/90 mmHg) - history of cardiovascular disease - history of cancer - history of diabetes - history of kidney disease - obesity (BMI > 30 kg/m2) - smoking or tobacco use - current pregnancy - nursing mothers - communication barriers

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Normal hydration
see description in 'arms'
Dehydration
see description in 'arms'

Locations

Country Name City State
United States William B Farquhar Newark Delaware

Sponsors (3)

Lead Sponsor Collaborator
University of Delaware National Heart, Lung, and Blood Institute (NHLBI), National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Robinson AT, Babcock MC, Watso JC, Brian MS, Migdal KU, Wenner MM, Farquhar WB. Relation between resting sympathetic outflow and vasoconstrictor responses to sympathetic nerve bursts: sex differences in healthy young adults. Am J Physiol Regul Integr Comp — View Citation

Watso JC, Babcock MC, Robinson AT, Migdal KU, Wenner MM, Stocker SD, Farquhar WB. Water deprivation does not augment sympathetic or pressor responses to sciatic afferent nerve stimulation in rats or to static exercise in humans. J Appl Physiol (1985). 201 — View Citation

Watso JC, Robinson AT, Babcock MC, Migdal KU, Wenner MM, Stocker SD, Farquhar WB. Short-term water deprivation does not increase blood pressure variability or impair neurovascular function in healthy young adults. Am J Physiol Regul Integr Comp Physiol. 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Pressure Variability Blood pressure variability (BPV) was calculated using standard deviation and using the average real variability index of blood pressure values. The average real variability index calculates the average of absolute differences between consecutive BP measurements and is thought to provide further prognostic value compared with traditional measures of BPV. During experimental visits 1 and 2
Primary Blood Pressure Reactivity - Handgrip Exercise Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest). During experimental visits 1 and 2