Status:
COMPLETED
A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Pre-diabetes
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular i...
Detailed Description
Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist circumference \>40inches in men, \>35 inches in women elevated triglycerides \>150mg/dL reduced HDL \<40mg/dL in men...
Eligibility Criteria
Inclusion
- 21-75 years
- Metabolic syndrome (3 of the 5 components)
- Elevated waist circumference \>40inches in men, \>35inches in women
- Elevated triglycerides \>150mg/dL
- Reduced HDL \<40mg/dL in men, \<50mg/dL in women
- Elevated blood pressure \>130mmHg systolic, \>85mmHg diastolic
- Elevated fasting glucose \>100mg/dL
Exclusion
- Diabetes mellitus
- Stage 3 hypertension \>180mmHg systolic, \>110mmHg diastolic office blood pressure
- History of non-diabetic kidney disease
- Myocardial infarction of unstable angina within the past 6 months
- History of liver disease
- History of malignancy
- History of drug or alcohol abuse
- Treatment with corticosteroids
- Pregnancy or lactating women of women of child bearing potential who are not willing to use reliable contraception method during the study
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00831129
Start Date
September 1 2006
End Date
April 1 2011
Last Update
February 10 2017
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637