Aldosterone and the Metabolic Syndrome

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-09-30

Brief Summary

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

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Detailed Description

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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

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Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HCTZ plus ALI 150 then ALI 300

Hydrochlorothiazide (HCTZ) 12.5mg daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 150 mg (ALI 150) daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 300mg ((ALI 300) for 1 month

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide (HCTZ)

Intervention Type DRUG

HCTZ 12.5mg daily

Aliskiren 150 mg (ALI 150)

Intervention Type DRUG

Aliskiren 150mg daily

Aliskiren 300 mg (ALI 300)

Intervention Type DRUG

Aliskiren 300mg daily

HCTZ plus ALI 150 then ALI 150 and SPL 25

HCTZ 12.5mg daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25mg (SPL 25) daily for one month

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide (HCTZ)

Intervention Type DRUG

HCTZ 12.5mg daily

Aliskiren 150 mg (ALI 150)

Intervention Type DRUG

Aliskiren 150mg daily

Spironolactone (SPL 25)

Intervention Type DRUG

spironolactone 25mg daily

HCTZ plus SPL 25 then SPL 50

HCTZ 12.5mg daily for 1 month

then HCTZ 12.5mg daily plus Spironolactone 25 mg (SPL 25) daily for 1 month

then HCTZ 12.5mg daily plus Spironolactone 50 mg daily for one month

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide (HCTZ)

Intervention Type DRUG

HCTZ 12.5mg daily

Spironolactone (SPL 25)

Intervention Type DRUG

spironolactone 25mg daily

Spironolactone 50 mg (SPL 50)

Intervention Type DRUG

Spironolactone 50 mg daily

HCTZ plus SPL 25 then ALI 150 and SPL 25

HCTZ 12.5mg daily for 1 month

then HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide (HCTZ)

Intervention Type DRUG

HCTZ 12.5mg daily

Aliskiren 150 mg (ALI 150)

Intervention Type DRUG

Aliskiren 150mg daily

Spironolactone (SPL 25)

Intervention Type DRUG

spironolactone 25mg daily

Interventions

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Hydrochlorothiazide (HCTZ)

HCTZ 12.5mg daily

Intervention Type DRUG

Aliskiren 150 mg (ALI 150)

Aliskiren 150mg daily

Intervention Type DRUG

Spironolactone (SPL 25)

spironolactone 25mg daily

Intervention Type DRUG

Aliskiren 300 mg (ALI 300)

Aliskiren 300mg daily

Intervention Type DRUG

Spironolactone 50 mg (SPL 50)

Spironolactone 50 mg daily

Intervention Type DRUG

Other Intervention Names

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HCTZ Tekturna Aldactone Tekturna Aldactone

Eligibility Criteria

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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)
3. Increased triglyceride level \> 150mg/dL
4. Decreased levels of High-Density Lipoprotein (HDL) cholesterol

1. For males, less than 30 mg/dL
2. For females, less than 40 mg/dL
5. Waist circumference

1. For males, greater than 40 inches.
2. For females, greater than 35 inches.

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
10. Diagnosis of asthma requiring use of inhaled beta agonist \>1 time per week
11. Clinically significant gastrointestinal impairment that could interfere with drug absorption
12. Impaired hepatic function \[aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) \>1.5 x upper limit of normal range\]
13. Impaired renal function \[estimated glomerular filtration rate (eGFR) of \<60ml/min\] as determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine (Scr) is expressed in mg/dl and age in years:

eGFR (ml/min/1.73m2)=175 • Scr-1.154 • age-0.203 • (1.212 if black) • (0.742 if female)
14. Hematocrit \<35%
15. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult, such as arthritis treated with non-steroidal antiinflammatory drugs
16. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
17. Treatment with lithium salts
18. History of alcohol or drug abuse
19. Treatment with any investigational drug in the 1 month preceding the study
20. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
21. Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
22. Screening plasma potassium \<3.2 mmol/L or use of chronic potassium supplements for the treatment of hypokalemia

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No