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Aldosterone and the Metabolic Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Aldosterone and the Metabolic Syndrome

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

NCT01103245•Vanderbilt University Medical Center

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects meeting all of the following conditions will be included in the study:
•1. Ambulatory subjects, 18 to 70 years of age, inclusive
•2. For female subjects, the following conditions must be met:
•1. postmenopausal status for at least 1 year, or
•2. status-post surgical sterilization, or
•3. if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day.
•3. A seated or supine systolic blood pressure greater than 130/85 on three separate measurements at least 15 minutes apart
•4. Metabolic Syndrome as defined by the presence of \> 3 of the following:
•1. Hypertension as characterized by having Systolic Blood Pressure \> 140 mm Hg and Diastolic Blood Pressure \> 90 mm Hg.
•2. Impaired Glucose Tolerance (Fasting Plasma Glucose \> 100 mg/dL)
+7 more criteria

Exclusion Criteria

•Subjects presenting with any of the following will not be included in the study:
•1. Diabetes type 1 or type 2, a fasting glucose of greater than 110 mg/dL or the use of anti-diabetic medication
•2. Use of hormone replacement therapy
•3. Statin therapy
•4. Pregnancy
•5. Breast-feeding
•6. Cardiovascular disease such as prior myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure \[Left Ventricular (LV) hypertrophy acceptable\], deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
•7. Treatment with anticoagulants
•8. History of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attack
•9. History or presence of immunological or hematological disorders
+14 more criteria

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

July 1, 2012

Completion Date

September 1, 2013

Last Updated

November 5, 2018

Enrollment

ACTUAL participants

Conditions

Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesGlucose Metabolism Disorders

Interventions

Hydrochlorothiazide (HCTZ)

DRUG

Aliskiren 150 mg (ALI 150)

DRUG

Spironolactone (SPL 25)

DRUG

Aliskiren 300 mg (ALI 300)

DRUG

Spironolactone 50 mg (SPL 50)

DRUG

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

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RECRUITINGNA

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Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Aldosterone and the Metabolic Syndrome

Inclusion Criteria

Exclusion Criteria

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