- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03560869
The Effect of Acute Mild Dehydration on Blood Pressure Control
January 5, 2021 updated by: University of Delaware
Sympathetic Reactivity to Water Restriction in Young and Older Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Delaware
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Newark, Delaware, United States, 19713
- William B Farquhar
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normal hydration then dehydration
Participants will consume water to maintain proper hydration for three days prior to testing (visit 1).
Seven to 60 days later, participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing (visit 2).
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see description in 'arms'
see description in 'arms'
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Experimental: Dehydration than normal hydration
Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing (visit 1).
Seven to 60 days later, participants will consume water to maintain proper hydration for three days prior to testing (visit 2).
|
see description in 'arms'
see description in 'arms'
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure Variability
Time Frame: During experimental visits 1 and 2
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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.
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During experimental visits 1 and 2
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Blood Pressure Reactivity - Handgrip Exercise
Time Frame: During experimental visits 1 and 2
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Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest).
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During experimental visits 1 and 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. 2020 Jan 1;318(1):R112-R121. doi: 10.1152/ajpregu.00149.2019. Epub 2019 Oct 16.
- 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). 2019 Jul 1;127(1):235-245. doi: 10.1152/japplphysiol.00005.2019. Epub 2019 May 9.
- 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 Physiol. 2019 May 1;316(5):R463-R471. doi: 10.1152/ajpregu.00305.2018. Epub 2019 Feb 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2017
Primary Completion (Actual)
June 13, 2019
Study Completion (Actual)
June 13, 2019
Study Registration Dates
First Submitted
June 6, 2018
First Submitted That Met QC Criteria
June 6, 2018
First Posted (Actual)
June 18, 2018
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1097747
- R01HL128388 (U.S. NIH Grant/Contract)
- 5P20GM113125 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Dehydration
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Rhode Island HospitalInternational Centre for Diarrhoeal Disease Research, Bangladesh; Fogarty International...Completed
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Wayne State UniversityUniversity of ChicagoUnknown
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