The Diurnal Rhythm in Natriuretic Peptide Levels

January 10, 2024 updated by: Pankaj Arora, MD, University of Alabama at Birmingham

The Diurnal Rhythm in Natriuretic Peptide Levels and Relationship With Nocturnal Blood Pressure

The purpose of the study to assess the diurnal rhythm in natriuretic peptide levels and its temporal relationship with nocturnal blood pressure in obese and African-American individuals as compared with lean and white individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obese and African-American individuals are at greater risk for cardiovascular morbidity and mortality than lean and white individuals. One of the key reasons for this health disparity is a higher risk of hypertension among obese and African-American individuals. The reasons for why these disparities develop are not well understood.

Natriuretic peptides are hormones produced by the heart and have a wide range of favorable cardiovascular effects such as natriuresis (sodium excretion), vasodilation, and direct inhibition of the renin-angiotensin-aldosterone system. Human studies showed the existence of 24-hour (diurnal) variations in the circulating natriuretic peptide levels.

Prior work from the investigators and others demonstrated that individuals with genetically-determined lower circulating natriuretic peptides levels have higher blood pressure and greater risk of hypertension. Further, the investigators have shown that obesity and African-American race are associated with lower natriuretic peptide levels, suggesting that relatively low natriuretic peptide levels may be a biologic determinant contributing to health disparities.

Obese and African-American individuals have a greater prevalence of nocturnal hypertension [nighttime blood pressure >120/80 mmHg], which is an independent risk factor for cardiovascular events. The underlying reasons for 24-hour variations in blood pressure are unknown.

The investigators hypothesize that loss of the natural 24-hour rhythm of natriuretic peptide levels plays a role in the development of nocturnal hypertension in obese and African-American individuals. The aims of this study are:

  1. to examine whether there is a presence of a 24-hour rhythm in natriuretic peptide levels among normotensive obese and African-American individuals and whether there is a difference in the rhythmicity of natriuretic peptide levels between obese and lean as well as in African-Americans and whites;
  2. to examine whether there is an existence of a relationship between 24-hour variability of natriuretic peptide levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of natriuretic peptide levels and nocturnal blood pressure differed in obese and lean individuals and by race.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 to 40 years
  • Blood pressure less than 140/90
  • Body Mass Index between 18.5 to 25 kg/m2 (lean) or 30 to 45 kg/m2 (obese)
  • Self identified African-American or white individuals
  • Willingness to comply with the study diet
  • Provide informed consent

Exclusion Criteria:

  • History of hypertension
  • History of cardiovascular, renal, or liver disease
  • Diabetes or use of glucose-lowering medications
  • Use of vasoactive or diuretic medications
  • Atrial fibrillation
  • Anemia (Hematocrit <41%)
  • Abnormal serum sodium or potassium
  • Abnormal liver function tests (>3x upper limit of normal)
  • Current smokers
  • Regular users of non-steroid anti-inflammatory medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study Individuals
Healthy self-identified African-American and white male participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
Other: standardized Study Diet
Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma MRproANP
Time Frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days
Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals
About 24 hours on the in-patient study visit day after consuming study meals for 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm
Time Frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days
Assess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race
About 24 hours on the in-patient study visit day after consuming study meals for 5 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma MRproANP
Time Frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days
Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals
About 24 hours on the in-patient study visit day after consuming study meals for 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Pankaj Arora, MD, University of Alabama at Birmingham
  • Principal Investigator: Orlando M Gutierrez, MMSc, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

February 6, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (Actual)

February 7, 2019

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-300002114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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