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