Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 83 of 221 for:    Aldosterone

Lysine-specific Demethylase 1 and Salt-sensitivity in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03029806
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Other: Aldosterone response to AngII LS Other: Renal blood flow response to salt Other: Vascular Stiffness Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Heathy volunteers
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Lysine-specific Demethylase 1 and Salt-sensitivity in Humans
Actual Study Start Date : January 2, 2017
Estimated Primary Completion Date : January 2, 2021
Estimated Study Completion Date : January 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Sodium

Arm Intervention/treatment
Active Comparator: Afr-Amer risk allele
African Americans carrying the LSD1 affected allele
Other: Aldosterone response to AngII LS
Change in aldosterone from baseline to after Ang II infusion on a LS diet

Other: Renal blood flow response to salt
Change in renal blood flow: High salt to low salt diet

Other: Vascular Stiffness
Change in vascular stiffness, baseline compared to AngII

Placebo Comparator: Cauc risk allele
Caucasians carrying the LSD1 affected allele
Other: Aldosterone response to AngII LS
Change in aldosterone from baseline to after Ang II infusion on a LS diet

Other: Renal blood flow response to salt
Change in renal blood flow: High salt to low salt diet

Other: Vascular Stiffness
Change in vascular stiffness, baseline compared to AngII

Placebo Comparator: Afr-Amer non-risk allele
African Americans carrying the LSD1 non-risk allele
Other: Aldosterone response to AngII LS
Change in aldosterone from baseline to after Ang II infusion on a LS diet

Other: Renal blood flow response to salt
Change in renal blood flow: High salt to low salt diet

Other: Vascular Stiffness
Change in vascular stiffness, baseline compared to AngII

Placebo Comparator: Cauc non-risk allele
Caucasians carrying the LSD1 non-risk allele
Other: Aldosterone response to AngII LS
Change in aldosterone from baseline to after Ang II infusion on a LS diet

Other: Renal blood flow response to salt
Change in renal blood flow: High salt to low salt diet

Other: Vascular Stiffness
Change in vascular stiffness, baseline compared to AngII




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029806


Contacts
Layout table for location contacts
Contact: Jonathan S Williams, MD, MMSc 6172780882 jwilliams5@bwh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jonathan S Williams, MD, MMSc         
Principal Investigator: Jonathan S Williams, MD, MMSc         
Sponsors and Collaborators
Brigham and Women's Hospital

Publications:
Layout table for additonal information
Responsible Party: Jonathan S. Williams, MD, MMSc, Associate Physician, Brigham and Women's Hospital, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03029806     History of Changes
Other Study ID Numbers: 2015P002540
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared first thru the publication of research results in peer-review scientific journals by the study investigator. IPD will be made available upon reasonable request from bona fide research organizations in an effort to provide broader impact and enrich public health knowledge. Research volunteer PHI will not be shared, and all participant data will be de-identified and coded. Only encrypted and secure network exchanges will be used for data transfer. Cost sharing my be required in order prepare datasets.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Immune System Diseases