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NCT Number: NCT03029806

Lysine-specific Demethylase 1 and Salt-sensitivity in Humans

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aldosterone response to AngII LS

Other

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

Renal blood flow response to salt

Other

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

Vascular Stiffness

Other

Change in vascular stiffness, baseline compared to AngII

Primary outcomes

  1. Aldosterone response to angiotensin II

    Time frame: After 1 week dietary salt manipulation

    Change in aldosterone, baseline to after angiotensin II by genotype/race

Secondary outcomes

  1. Renal blood flow response to dietary salt

    Time frame: After 1 week dietary salt manipulation on both diets

    Change in renal blood flow, high salt diet to low salt diet by genotype/race

  2. Vascular stiffness response to angiotensin II

    Time frame: After 1 week dietary salt manipulation

    Change in vascular stiffness, baseline to after angiotensin II by genotype/race

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2026
First posted
Jan 24, 2017
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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