COMPLETED

Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese African Americans

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Experimental data have shown that timing of sodium intake impacts diurnal patterns of sodium excretion. The purpose of this study is to test the hypothesis that the time of day for salt intake impacts (1) blood pressure rhythms and urinary sodium excretion and (2) circadian timing of factors responsible for blood pressure regulation and cardiometabolic health in obese individuals. These studies will address two aims. The first aim will test the hypothesis that limiting high salt intake prior to sleep increases day-night differences in blood pressure, improves timing of urinary sodium excretion, and improves metabolic risk factors. The second aim will test the hypothesis that limiting high salt intake prior to sleep preferentially improves rhythmicity in peripheral vs. central circadian clock factors linked to renal sodium handling. The proposed hypothesis-driven studies will determine how timing of sodium intake affects diurnal blood pressure and circadian timing of factors responsible for blood pressure control and metabolic health, with the ultimate goal of identifying novel strategies to treat nocturnal hypertension and metabolic disease in obesity.

Official Title

Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese

Quick Facts

Study Start:2020-07-14
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04021355

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.

Ages Eligible for Study:25 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * obese (BMI 30-50 kg/m2)
  2. * 25-45 years of age
  1. * evidence of kidney disease (eGFR \< 60 ml/min/1.73m2 or abnormal urinalysis)
  2. * elevated BP (\>150/90 mmHg \[measured at screening in duplicate after 10min lying recumbent\])
  3. * elevated fasting glucose (\>126 g/dL on screening labs)
  4. * severe anemia (hemoglobin \< 8 g/dL for women or \< 9 g/dL for men)
  5. * significant psychiatric illness (as assessed by a validated screening form)
  6. * past or present drug or alcohol abuse (drug screen)
  7. * taking 2 or more BP medications or supplements on a regular basis
  8. * alcohol intake more than 2 drinks/day
  9. * pregnancy
  10. * women taking hormone replacement therapy, or post-menopausal women;
  11. * shift worker
  12. * sleep disorders (such as sleep apnea assessed by Apnea Link)
  13. * major chronic disease (e.g., diabetes, lymphocyte disorders)
  14. * history of smoking or use of tobacco products within the past year
  15. * use of sleep medications, hypnotics, stimulants, or anti-depressants

Contacts and Locations

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2020-07-14
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2020-07-14
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Hypertension
  • Circadian Dysregulation
  • Salt; Excess