Blood Pressure and Diurnal Variation in Sodium, Potassium, and Water Excretion

To determine if hypertensives and normotensives of similar ages had, on average, different ratios of 24-hour to overnight excretion of sodium, potassium, and water. Also, to determine the number of 24-hour collections needed to characterize individuals with respect to the ratios of 24-hour to overnight excretion and to determine if the ratios of 24-hour to overnight excretion vary by age and other factors related to blood pressure.

Study Overview

Detailed Description

BACKGROUND:

For decades excess sodium intake has been implicated in the etiopathogenesis of high blood pressure. Data from epidemiological, clinical, and animal experimental studies all suggest a direct casual association between excess salt intake and hypertension. Several investigators suggest that hypertension is the result of an inability of the kidney to excrete salt and water normally. It is hypothesized that the development of chronic blood pressure elevation results from the kidney's need to increase urine volume and sodium excretion -- in the presence of habitual high sodium intake -- in order to maintain homeostasis of the extracellular fluid volume.

Diurnal variations in excretion of sodium, chloride, potassium and water have been observed in several studies. Water and electrolyte excretion in normal individuals generally reaches a maximum sometime around midday with a minimum toward the end of the sleep period. These studies suggest that the daytime excretion rate exceeds the nighttime rate by 50 to 100 percent. Overnight urine collections have been used in many studies since they are easier to obtain, but they do not provide a direct estimate of the actual intake of sodium or potassium. In order to estimate actual intake, overnight values must be corrected to 24-hour values, that is, by multiplying the overnight values by previously determined ratios of 24-hour to overnight excretions. Preliminary studies by this group of investigators in hypertensives were the first which computed 24-hour to overnight ratios for excretion of sodium, potassium and creatinine in a definite way. This study in hypertensives showed a reversal of the diurnal cycle of sodium excretion. What is not clear in this study and others is whether the reversal is associated with hypertension or reflects decreased renal function with age or whether deterioration of renal function is due to the kidney readjusting its output of salt and water to maintain homeostasis in the face of both an excess sodium intake and a highly variable day to day intake. In addition, it may be that an abnormal diurnal pattern of sodium excretion may indicate that one is at risk of development of hypertension.

DESIGN NARRATIVE:

Each participant provided three 24-hour urine collections, divided into daytime and overnight specimens for the assessment of sodium, potassium, creatinine, and water excretion. Four blood pressure measurements were made. Height and weight were measured. Information was collected on demographic variables, alcohol intake, history and treatment of blood pressure, medication use, family history of high blood pressure, cigarette use, and changes in dietary habits. Analysis of variance was the primary method of data analysis.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

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

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

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?

Collaborators and Investigators

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Study record dates

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Study Major Dates

Study Start

August 1, 1987

Study Completion (Actual)

July 1, 1989

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

November 1, 2001

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1083
  • R01HL038897 (U.S. NIH Grant/Contract)

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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