Nocturnal Hypertension and Non-Dipping Blood Pressure

NCT ID: NCT03128177

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover study of high (6 g) and low (1.5 g) sodium diet
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Both the participant and investigator are blinded to the diet

Study Groups

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High sodium diet

High sodium diet is 6 g sodium per day for 10 days

Group Type EXPERIMENTAL

Dietary sodium

Intervention Type DIETARY_SUPPLEMENT

High (6 g) versus low (1.5 g) sodium diet

Low sodium diet

Low sodium diet is 1.5 g sodium per day for 10 days

Group Type EXPERIMENTAL

Dietary sodium

Intervention Type DIETARY_SUPPLEMENT

High (6 g) versus low (1.5 g) sodium diet

Interventions

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Dietary sodium

High (6 g) versus low (1.5 g) sodium diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

48 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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David Calhoun

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Calhoun, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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David A. Calhoun, MD

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F150508004

Identifier Type: -

Identifier Source: org_study_id

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