Clinical trial NCT00831129: A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs
Official title: Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pre-diabetes
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-01-28
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.

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\<50 in women elevated blood pressure \>130mmHg systolic, or \>85mmHg diastolic elevated fasting glucose \>100mg/dL

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in High-sensitivity C-reactive Protein
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Urinary Isoprostane
timeFrame: Baseline and 6 months
measure: Change in Malondialdehyde
timeFrame: Baseline and 6 months
measure: Change in Office Systolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Change in Office Diastolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Change in Low-density Lipoprotein
timeFrame: Baseline and 6 months
measure: Change in Triglycerides
timeFrame: Baseline and 6 months
measure: Change in High-density Lipoprotein
timeFrame: Baseline and 6 months
measure: Change in Glycosylated Haemoglobin
timeFrame: Baseline and 6 months
measure: Change in Fasting Blood Glucose
timeFrame: Baseline and 6 months
measure: Change in Insulin
timeFrame: Baseline and 6 months
measure: Change in Homeostatic Model Assessment for Insulin Resistance
timeFrame: Baseline and 6 months
measure: Change in Adiponectin
timeFrame: Baseline and 6 months
measure: Change in Body Mass Index
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: George Bakris, M.D.
role: PRINCIPAL_INVESTIGATOR
References: