NCT01103245

Aldosterone and the Metabolic Syndrome

Aldosterone and the Metabolic Syndrome: Renin Inhibition Versus Mineralocorticoid Receptor (MR) Antagonism

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on fasting blood glucose and glucose-stimulated insulin secretion in humans.

Conditions

• Metabolic Diseases
• Diabetes Mellitus
• Endocrine System Diseases
• Glucose Metabolism Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-07-01
• Completion: 2013-09-01
• First posted: 2010-04-14
• Last updated: 2018-11-05
• Results posted: 2018-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study