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Nocturnal Hypertension and Non-Dipping Blood Pressure

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT03128177
Collaborator
American Heart Association (Other)
59
Enrollment
1
Location
2
Arms
51
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary sodium
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover study of high (6 g) and low (1.5 g) sodium dietCrossover study of high (6 g) and low (1.5 g) sodium diet
Masking:
Double (Participant, Investigator)
Masking Description:
Both the participant and investigator are blinded to the diet
Primary Purpose:
Treatment
Official Title:
Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 24-hour blood pressure [Baseline to 7 days after start of dietary period]

    Blood pressure measured by an ambulatory blood pressure monitor

Secondary Outcome Measures

  1. Obstructive sleep apnea [Baseline to 7 days after start of dietary period]

    Severity of obstructive sleep apnea as determine by the apnea hypopnea index

Eligibility Criteria

Criteria

Ages Eligible for Study:
48 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 David A. Calhoun, MD Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham
  • American Heart Association

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Calhoun, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT03128177
Other Study ID Numbers:
  • F150508004
First Posted:
Apr 25, 2017
Last Update Posted:
Jun 11, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Calhoun, Professor, University of Alabama at Birmingham
nocturnal hypertension
non-dipping blood pressure
obstructive sleep apnea
Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertension

Study Results

No Results Posted as of Jun 11, 2020