Studies on Aldosterone and Vascular Function

Phase 1

Completed

• Conditions: Inflammation
• Interventions: Dietary Supplement: low or high sodium diet; Drug: aldosterone; Drug: placebo

• Registration Number: NCT00700479
• Lead Sponsor: Yale University

Brief Summary

A randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-25
• Status Verified: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted QC: 2008-06-17
• Last Update Submitted: 2008-06-17
• Study First Posted: 2008-06-18
• Last Update Posted: 2008-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy subjects age >18 years

Exclusion Criteria

• Any chronic medical disease or chronic use of medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C	placebo	Placebo plus low sodium diet
D	low or high sodium diet	placebo plus high sodium diet
A	aldosterone	Aldosterone plus low salt diet
A	low or high sodium diet	Aldosterone plus low salt diet
B	low or high sodium diet	Aldosterone plus high sodium diet
C	low or high sodium diet	Placebo plus low sodium diet
D	placebo	placebo plus high sodium diet
B	aldosterone	Aldosterone plus high sodium diet

Primary Outcome Measures

Name	Time	Method
Flow mediated dilation brachial artery	0 and 4 hours

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States