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Aldosterone and the Metabolic Syndrome

NCT01103245 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2018-11-05

Study results available
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Summary

The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans.

Conditions

Interventions

DRUG

Hydrochlorothiazide (HCTZ)

HCTZ 12.5mg daily

DRUG

Aliskiren 150 mg (ALI 150)

Aliskiren 150mg daily

DRUG

Spironolactone (SPL 25)

spironolactone 25mg daily

DRUG

Aliskiren 300 mg (ALI 300)

Aliskiren 300mg daily

DRUG

Spironolactone 50 mg (SPL 50)

Spironolactone 50 mg daily

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • James M Luther, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-07-31
Completion
2013-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103245 on ClinicalTrials.gov