Recruiting

Observational Study

Sponsor:

University of Delaware

Code:

NCT06094816

Conditions

Salt-Sensitivity of Blood Pressure

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Accepted

Interventions

Furosemide (Diuretic)

Hypertonic Saline Infusion

Study Details

Brief summary:

The overall objective of this project is to identify the key salt-sensing regions of the brain and determine the underlying mechanism of sodium sensing. The investigators will assess how the brain responds to an acute increase of salt in the blood using MRI. This will be done during a 30-minute infusion of a saline solution containing 3% salt. One trial will be conducted with a salt sensing channel blocker and one trial without the salt sensing channel blocker. This will help to assess the role of a specific salt sensing channel in the brain. Salt sensitivity of BP will be assessed using 7-day dietary feeding where participants will be given food to consume for 7-days. Comparisons will be made between salt resistant (no change in blood pressure going from low to high salt diets) and salt sensitive adults (a change in blood pressure going from low to high salt diets). The investigators think the changes in MRI will be greater in salt sensitive compared to salt resistant subjects.

Conditions

Salt-Sensitivity of Blood Pressure

Study ID

NCT06094816

Start date

Mar 5, 2024

Status verified date

Mar, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age: > 40 years or < 60 years
  • Blood pressure: > 100/60 mmHg or < 140/90 mmHg
  • BMI: > 18.5 kg/m2 or < 35 kg/m2
  • Serum potassium: > 3.5 mmol/L or < 5.5 mmol/L
  • No history of cardiovascular, renal, metabolic, or neurological disease

Exclusion Criteria:

  • Age: < 40 years or > 60 years
  • Blood pressure: < 100/60 mmHg or > 140/90 mmHg
  • BMI: < 18.5 kg/m2 or > 30 kg/m2
  • Serum potassium: < 3.5 mmol/L or > 5.5 mmol/L
  • Abnormal ECG
  • History of - cardiovascular, cancer, metabolic, respiratory, renal disease
  • Hormone replacement therapy
  • Current tobacco or nicotine use
  • Pregnant or nursing mothers
  • Major brain injury (concussions do not count)
  • Clinically diagnosed psychiatric or neurological disorder
  • Clinically diagnosed anxiety or depression
  • Psychiatric, neurological, anxiety or depression medications
  • Hypertension medications
  • Sulfonamide drug allergy
  • Contra-indications to MRI (implants, metal, etc)
  • Claustrophobia

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Salt Resistant Adults

Adults who experience minimal BP change during dietary sodium challenge

experimental: Salt Sensitive

Adults who experience increased BP (mean arterial pressures >5mmHg) during dietary sodium challenge

Interventions

Furosemide (Diuretic)

The diuretic furosemide will be given during a 3% hypertonic saline infusion to examine blockade of the NKCC2.

Hypertonic Saline Infusion

3% Hypertonic saline infusion to acutely increase sodium and osmolality

Primary outcome measure

  • Bold fMRI [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Megan Wenner, PhD

3028317343mwenner@udel.edu

Virginia Nuckols, PhD

gnuckols@udel.edu

Locations

University of Delaware

Recruiting

Newark, Delaware, United States, 19713

Contacts

Ginny Nuckols, PhD

gnuckols@udel.edu

Katherine Masso, BS

kcmasso@udel.edu

More Information

Sponsor

University of Delaware

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Delaware on 2026-03-24.