Nocturnal Hypertension and Non-Dipping Blood Pressure

NCT03128177 | Completed DMC

• 1 other identifier: F150508004
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obstructive Sleep Apnea

Keywords

nocturnal hypertension; non-dipping blood pressure; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• 24-hour blood pressure

  Blood pressure measured by an ambulatory blood pressure monitor

  Baseline to 7 days after start of dietary period

Secondary Outcomes (1)

• Obstructive sleep apnea

  Baseline to 7 days after start of dietary period

Study Arms (2)

High sodium diet

EXPERIMENTAL

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

Dietary Supplement: Dietary sodium

Low sodium diet

EXPERIMENTAL

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

Dietary Supplement: Dietary sodium

Interventions

Dietary sodium DIETARY_SUPPLEMENT

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

High sodium diet; Low sodium diet

Eligibility Criteria

• Age: 48 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nocturnal hypertension

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Heart Association: collaborator

Study Sites (1)

David A. Calhoun, MD

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive

Interventions

Sodium, Dietary

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sodium Compounds; Inorganic Chemicals

Study Officials

• David Calhoun, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the participant and investigator are blinded to the diet
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Crossover study of high (6 g) and low (1.5 g) sodium diet

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: January 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)