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Studies on Aldosterone and Vascular Function

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldosterone
low or high sodium diet
placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammation focused on measuring vascular endothelium, nitric oxide, aldosterone, vascular biology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy subjects age >18 years

Exclusion Criteria:

  • Any chronic medical disease or chronic use of medications

Sites / Locations

  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

Aldosterone plus low salt diet

Aldosterone plus high sodium diet

Placebo plus low sodium diet

placebo plus high sodium diet

Outcomes

Primary Outcome Measures

Flow mediated dilation brachial artery

Secondary Outcome Measures

Full Information

First Posted
December 25, 2007
Last Updated
June 17, 2008
Sponsor
Yale University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00700479
Brief Title
Studies on Aldosterone and Vascular Function
Official Title
Studies on Aldosterone and Vascular Function
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
vascular endothelium, nitric oxide, aldosterone, vascular biology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Aldosterone plus low salt diet
Arm Title
B
Arm Type
Experimental
Arm Description
Aldosterone plus high sodium diet
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Placebo plus low sodium diet
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
placebo plus high sodium diet
Intervention Type
Drug
Intervention Name(s)
aldosterone
Intervention Description
4 hour infusion
Intervention Type
Dietary Supplement
Intervention Name(s)
low or high sodium diet
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Flow mediated dilation brachial artery
Time Frame
0 and 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects age >18 years Exclusion Criteria: Any chronic medical disease or chronic use of medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Katz, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

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Studies on Aldosterone and Vascular Function

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