Overview

Diurnal Variation of Plasminogen Activator Inhibitor-1

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
Summary
To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vanderbilt University Medical Center
Collaborator:
National Center for Research Resources (NCRR)
Treatments:
Eplerenone
Plasminogen
Plasminogen Activator Inhibitor 1
Plasminogen Inactivators
Spironolactone
Criteria
Inclusion Criteria:

- Age18-65

- Metabolic Syndrome (3 or more of the following):

1. Blood pressure 130/85 or greater

2. Central obesity (Waist - Male > 40", Female > 35")

3. Fasting glucose ≥ 110 mg/dl

4. Low HDL (Male < 40 mg/dl, Female < 50 mg/dl)

5. Elevated Triglycerides (> 150 mg/dl)

Exclusion Criteria:

- Cigarette Use

- Renal insufficiency

- Coronary Artery Disease

- Diabetes

- Blindness

- Cerebrovascular Disease

- Secondary hypertension (renal artery stenosis, pheo, etc.)

- RAAS disease (Primary Aldosteronism, etc.)

- Other chronic illness (cancer, autoimmune or liver disease)

- Pregnancy

- Anemia (Hgb < 12 mg/dl)

- Evening or Night Shift work

- Transmeridian travel in previous 6 months

- History of sleep disorders

- Hypokalemia (serum potassium < 3.5 milliequivalent (mEq/L)

- Hyperkalemia (serum potassium > 5.5 mEq/L

- Reported hypersensitivity to HCTZ or eplerenone