Aldosterone and Glucose Homeostasis

Determine the effect of aldosterone on glucose metabolism in humans.

Inclusion Criteria:

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

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Exclusion Criteria:

1. BMI greater than 31 kg/m2

2. Diabetes type 1 or type 2, a fasting glucose of greater than 110 mg/dL or
the use of anti-diabetic medication

3. Serum triglycerides greater than 150 mg/dL (1.7 mmol/L)

4. Total cholesterol greater than 200 mg/dL (5.18 mmol/L)

5. Use of hormone replacement therapy

6. Statin therapy

7. A seated or supine systolic blood pressure greater than 130/85 on three
separate measurements at least 15 minutes apart

8. Pregnancy

9. Breast-feeding

10. Cardiovascular disease such as myocardial infarction within 6 months prior
to enrollment, presence of angina pectoris, significant arrhythmia (atrial
fibrillation or ventricular tachycardia), congestive heart failure (LV
hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second
or third degree heart block, mitral valve stenosis, aortic stenosis or
hypertrophic cardiomyopathy

11. Treatment with anticoagulants

12. History of serious neurologic disease such as cerebral hemorrhage, stroke,
or transient ischemic attack

13. History or presence of immunological or hematological disorders

14. Diagnosis of asthma requiring use of inhaled beta agonist > 1 time per week

15. Clinically significant gastrointestinal impairment that could interfere
with drug absorption

16. Impaired hepatic function [aspartate amino transaminase (AST) and/or
alanine amino transaminase (ALT) >1.5 x upper limit of normal range]

17. Impaired renal function [estimated glomerular filtration rate (eGFR) of
<60ml/min]

18. Hematocrit <35%

19. 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

20. Treatment with chronic systemic glucocorticoid therapy (more than 7
consecutive days in 1 month)

21. Treatment with lithium salts

22. History of alcohol or drug abuse

23. Treatment with any investigational drug in the 1 month preceding the study

24. Mental conditions rendering the subject unable to understand the nature,
scope and possible consequences of the study

25. Inability to comply with the protocol, e.g. uncooperative attitude,
inability to return for follow-up visits, and unlikelihood of completing
the study

26. Potassium less than 3.5mmol/L or use of chronic potassium supplements.