Nocturnal Hypertension and Non-Dipping Blood Pressure

June 10, 2020 updated by: David Calhoun, University of Alabama at Birmingham

Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns

The purpose of this study is to determine if high salt diet contributes to high nighttime blood pressure. The investigators will determine if high compared to low salt diet increases 24-hour blood pressure levels. The investigators will also determine if high salt diet affects blood vessel stiffness, cardiac output, and sleep apnea. The study will also determine how high salt diet affects the activity of certain genes related to control of blood pressure. A total of 60 participants will be enrolled in the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

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
        • David A. Calhoun, MD

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

48 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nocturnal hypertension

Exclusion Criteria:

  • Stage 2 clinic hypertension
  • History of congestive heart failure
  • Chronic kidney disease,
  • Diabetes with insulin use
  • History of a cardiovascular event
  • Pregnant or nursing
  • Current use of continuous positive airway pressure
  • Shift work
  • A known circadian rhythm disorder

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High sodium diet
High sodium diet is 6 g sodium per day for 10 days
Dietary supplement: Dietary sodium
High (6 g) versus low (1.5 g) sodium diet
EXPERIMENTAL: Low sodium diet
Low sodium diet is 1.5 g sodium per day for 10 days
Dietary supplement: Dietary sodium
High (6 g) versus low (1.5 g) sodium diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour blood pressure
Time Frame: Baseline to 7 days after start of dietary period
Blood pressure measured by an ambulatory blood pressure monitor
Baseline to 7 days after start of dietary period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstructive sleep apnea
Time Frame: Baseline to 7 days after start of dietary period
Severity of obstructive sleep apnea as determine by the apnea hypopnea index
Baseline to 7 days after start of dietary period

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Collaborators

American Heart Association

Investigators

  • Principal Investigator: David Calhoun, MD, University of Alabama at Birmingham

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)

January 1, 2016

Primary Completion (ACTUAL)

March 31, 2020

Study Completion (ACTUAL)

March 31, 2020

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F150508004

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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