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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00608465 |
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Date of registration:
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22/01/2008 |
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Primary sponsor: |
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Public title:
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Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity
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Scientific title:
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Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00608465 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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James AS Muldowney, III, MD |
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Address:
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Telephone:
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615-936-1750 |
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Email:
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james.muldowney@vanderbilt.edu |
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Affiliation:
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Name:
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James AS Muldowney, III, MD |
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Address:
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Telephone:
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615-936-1719 |
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Email:
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james.muldowney@vanderbilt.edu |
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Affiliation:
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Name:
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James AS Muldowney, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or females between the ages of 18 to 65 years of age.
- Documented diagnosis for the metabolic syndrome:
- Subjects with hypertension (SP>130mmHg)
- Subjects with central obesity (females waist >35"; males waist >40")
- Subjects with dyslipidemia (HDL <40mg/dl, triglycerides > 150 mg/dl)
- Subjects who are insulin resistance (fasting glucose >100mg/dl)
Exclusion Criteria:
- Subjects who smoke
- Women who are pregnant (confirmed by urine beta-HCG).
- Women who are breast feeding
- Subjects with documentation of the following health risk:
- Subjects with serum creatinine >2.0 mg/dl (males), >1.8 mg/dl (females)
- Subjects whose creatinine clearance < 50 mls/min
- Subjects with serum potassium >5.5mEql
- Subjects with Type 2 diabetes with microalbuminuria (spot urine
protein/creatinine ration >0.2)
- Subjects who are currently taking the following medications:
- Warfarin
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metabolic Syndrome X
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Intervention(s)
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Drug: Eplerenone
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Drug: Ramipril
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Primary Outcome(s)
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Secreted factors from adipocytes have autocrine, paracrine and endocrine effects that have a deleterious effect on the fibrinolytic system, either by enhancing PAI-1 production or impairing endothelial t-PA release
[Time Frame: 10-Week period]
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This study will analyze patients' genetic make up to identify who may be at greater risk for heart disease and strokes in relationship to high blood pressure and central obesity.
[Time Frame: 10-weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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