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Clinical Trials/NCT02588352
NCT02588352CompletedNot Applicable

Evaluation of Salt Sensitivity in Young Adults

NYU Langone Health1 site in 1 country40 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Presence of salt sensitivity

Study Overview

Brief Summary

The current prospective cross-sectional pilot study is proposed to determine a set of characteristic factors associated with salt sensitivity in young adults by measuring blood pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central arterial pressure in response to short term increases in salt intake.

Detailed Description

Since salt sensitivity at an early age is associated with subsequent hypertension and an increase in mortality, intervention by lifestyle modification including the reduction of sodium intake could prevent subsequent increases in blood pressure and development of hypertension, cardiovascular disease and death. It would therefore be beneficial to have a simple method of identifying salt sensitive young adults so that risk factor modification can be achieved to prevent progression of the effects of hypertension on heart function.

This study is a longitudinal pilot study to identify characteristics of salt sensitive young adults so that this population of people can be identified early on and appropriate lifestyle modifications can be made to prevent the subsequent progression of hypertension and cardiovascular disease.

The study will be conducted at 2 visits separated by one week. At the first visit, eligible subjects will be asked to complete questionnaires regarding childhood and current sodium intake.Subjects will be asked about family history of hypertension and cardiovascular disease. Subjects will also undergo blood pressure measurement in both arm, and will provide a blood sample and spot urine sample. Subjects will then be asked to take salt pills 3 times a day for one week, and then return to the study center for a repeat of the above measurements.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
21 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Young adults age 21-30
  • •Able and willing to provide written informed consent

Exclusion Criteria

  • •Any cardiovascular or other chronic health problem
  • •Chronic medications besides oral contraceptive pills in women
  • •BMI>30kg/m2
  • •Blood pressure >140/90 mmHg
  • •Inability or unwillingness to adhere to study procedures

Arms & Interventions

Healthy volunteers

Experimental

Open label administration of salt tablets for one week

Intervention: Salt tablet (Dietary Supplement)

Outcomes

Primary Outcomes

Presence of salt sensitivity

Time Frame: Visit 1 (One Week)

Defined as an increase in mean arterial blood pressure greater than 5 mmHg

Secondary Outcomes

  • Change in aldosterone level(Baseline to Visit 2 (One Week))
  • Change in augmentation index (%)(Baseline to Visit 2 (One Week))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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