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Lysine-specific Demethylase 1 and Salt-sensitivity in Humans

Lysine-specific Demethylase 1 and Salt-sensitivity in Humans

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03029806
Enrollment
88
Registered
2017-01-24
Start date
2017-01-02
Completion date
2026-06-01
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

The purpose of this study is to investigate the role dietary salt plays in epigenetic regulation of blood pressure, focusing on the salt-sensitive regulatory enzyme Lysine-specific demethylase 1.

Detailed description

The purpose of this study is to investigate the role dietary salt plays in epigenetic regulation of blood pressure in African American and Caucasians, focusing on the salt-sensitive regulatory enzyme Lysine-specific demethylase 1. This might help us understand why some people develop high blood pressure. Healthy volunteers will be screened for eligibility and invited to participate in a 2 weeks study. Week 1 will be consumption of a low salt diet. Week 2 will be a high salt diet. At the end of each week, participants will be admitted to a Clinical Research Center overnight and for one day. On the CRC, participants will remain fasting and supine overnight and then next morning undergo hormonal and vascular testing. This will consist of blood drawing, echocardiogram, vascular tonometry, and assessment of renal blood flow before and after a low-dose Angiotensin II infusion. The study outcome will compare how variants in the LSD1 gene affect hormonal and vascular responses according to race. This information will help us determine why some races and genetic profiles are more susceptible to detrimental effects of salt in the diet while others are protected against these effects.

Interventions

OTHERAldosterone response to AngII LS

Change in aldosterone from baseline to after Ang II infusion on a LS diet

OTHERRenal blood flow response to salt

Change in renal blood flow: High salt to low salt diet

OTHERVascular Stiffness

Change in vascular stiffness, baseline compared to AngII

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Heathy volunteers

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 25-45 years * Caucasian or African American * No gender preference (anticipate 50% female) * Normotensive (screening blood pressure \<140/90 mmHg) * No history of hypertension, diabetes, stroke, coronary artery disease, kidney disease, cancer, thyroid disease, preeclampsia, or hospitalizations in 6 months * Normal screening laboratory values (CMP, TSH, A1c) * Normal ECG * BMI \<25 kg/m2

Exclusion criteria

* Pregnancy * Breast feeding * Any medication or herbal preparation * \>6oz alcohol/week * Tobacco use * Illicit drug use * Chronic NSAID use * Recent steroid use (injected, inhaled, oral) * Decongestant use in the past 2 weeks * Known sensitivity to infused Angiotensin II or para-amino hippurate

Design outcomes

Primary

MeasureTime frameDescription
Aldosterone response to angiotensin IIAfter 1 week dietary salt manipulationChange in aldosterone, baseline to after angiotensin II by genotype/race

Secondary

MeasureTime frameDescription
Renal blood flow response to dietary saltAfter 1 week dietary salt manipulation on both dietsChange in renal blood flow, high salt diet to low salt diet by genotype/race
Vascular stiffness response to angiotensin IIAfter 1 week dietary salt manipulationChange in vascular stiffness, baseline to after angiotensin II by genotype/race

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026