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Sodium Intake Modification for High Blood Pressure
N/A
Recruiting
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour
Awards & highlights
No Placebo-Only Group
Summary
This trial will help identify regions of the brain that help regulate blood pressure in response to changes in sodium levels.
Who is the study for?
This trial is for adults aged 18-45 with normal blood pressure and potassium levels, who have a BMI within the range of 18.5 to 30 kg/m2. It's designed for those without any known allergies or salt sensitivity issues that affect their blood pressure.
What is being tested?
The study aims to understand how the brain detects changes in blood sodium levels and its role in controlling blood pressure. Participants will undergo dietary interventions and receive hypertonic saline to identify key brain regions involved in sodium sensing.
What are the potential side effects?
Potential side effects may include discomfort from high salt intake such as thirst, increased urination, dizziness, or elevated blood pressure due to the hypertonic saline solution.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma arginine vasopressin concentration (pg/mL)
fMRI to assess SFO-OLVT functional connectivity (z-score)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Salt Sensitivity AssessmentExperimental Treatment1 Intervention
1 week high salt diet and 1 week low salt diet
Group II: Functional Magnetic Resonance ImagingExperimental Treatment1 Intervention
Hypertonic saline infusion perturbation with and without NKCC2 antagonism (furosemide) to examine sodium sensing mechanisms
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Who is running the clinical trial?
University of DelawareLead Sponsor
161 Previous Clinical Trials
25,602 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication for a psychiatric condition.I am between 18 and 45 years old.I am on hormone replacement therapy.I have a history of a metabolic disease.I have been diagnosed with an anxiety disorder.I am either younger than 18 or older than 45.I have a history of heart disease.My BMI is either below 18.5 or above 30.I have a history of kidney disease.I have had cancer in the past.I am taking medication for a neurological condition.I have not had a major brain injury.I have been diagnosed with a neurological disorder.I am taking medication for anxiety.I am taking medication for depression.I am taking medication for high blood pressure.I have been diagnosed with depression.I have a history of lung or breathing problems.
Research Study Groups:
This trial has the following groups:- Group 1: Salt Sensitivity Assessment
- Group 2: Functional Magnetic Resonance Imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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