Status:
TERMINATED
Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity
Lead Sponsor:
Vanderbilt University
Conditions:
Metabolic Syndrome X
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The combination of high blood pressure and having central obesity is an increasing important factor for heart disease in men and women. It can also lead to the early development of hardening of the ar...
Detailed Description
Obesity is an increasingly important risk factor for cardiovascular disease in men and women and is associated with the premature development of atherosclerosis, and increased risk of stroke. A classi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00608465
Start Date
May 1 2006
End Date
May 1 2011
Last Update
August 11 2017
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232