Diurnal Variation of Plasminogen Activator Inhibitor-1

Completed · Phase 4

Conditions studied: Metabolic Syndrome X

In brief

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.

Key facts

Study ID

NCT00515021

Run by

Vanderbilt University Medical Center

People needed

21

Starts

2007-04-01

Expected to finish

2010-04-01

Last updated by the study team

2019-02-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age18-65
• Metabolic Syndrome (3 or more of the following):
• Blood pressure 130/85 or greater
• Central obesity (Waist - Male > 40", Female > 35")
• Fasting glucose ≥ 110 mg/dl
• Low HDL (Male < 40 mg/dl, Female < 50 mg/dl)
• Elevated Triglycerides (> 150 mg/dl)

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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