A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Phase 2

Completed

• Conditions: Pre-diabetes
• Interventions: Drug: Placebo Rosiglitazone; Drug: Rosiglitazone; Drug: Simvastatin

• Registration Number: NCT00831129
• Lead Sponsor: University of Chicago

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

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Results First Submitted: 2013-06-27
• Results First Submitted QC: 2013-06-27
• Results First Posted: 2013-09-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin + Placebo Rosiglitazone	Placebo Rosiglitazone	Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily
Simvastatin + Placebo Rosiglitazone	Simvastatin	Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily
Simvastatin + rosiglitazone	Rosiglitazone	Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily
Simvastatin + rosiglitazone	Simvastatin	Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily

Primary Outcome Measures

Name	Time	Method
Change in High-sensitivity C-reactive Protein	Baseline and 6 months	change in high-sensitivity C-reactive between baseline and 6 month

Secondary Outcome Measures

Name	Time	Method
Change in Malondialdehyde	Baseline and 6 months	change in Malondialdehyde between baseline and 6 month
Change in Office Diastolic Blood Pressure	Baseline and 6 months	change in office diastolic blood pressure between baseline and 6 month
Change in Urinary Isoprostane	Baseline and 6 months	change in urinary isoprostane between baseline and 6 month
Change in Office Systolic Blood Pressure	Baseline and 6 months	change in office systolic blood pressure between baseline and 6 month
Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure	Baseline and 6 months	change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month
Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure	Baseline and 6 months	change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month
Change in Low-density Lipoprotein	Baseline and 6 months	change in low-density lipoprotein between baseline and 6 month
Change in Triglycerides	Baseline and 6 months	change in Triglycerides between baseline and 6 month
Change in Glycosylated Haemoglobin	Baseline and 6 months	change in glycosylated haemoglobin between baseline and 6 month
Change in Fasting Blood Glucose	Baseline and 6 months	change in fasting blood glucose between baseline and 6 month
Change in Insulin	Baseline and 6 months	change in Insulin between baseline and 6 month
Change in Homeostatic Model Assessment for Insulin Resistance	Baseline and 6 months	change in homeostatic model assessment for insulin resistance between baseline and 6 month
Change in High-density Lipoprotein	Baseline and 6 months	change in high-density lipoprotein between baseline and 6 month
Change in Adiponectin	Baseline and 6 months	change in Adiponectin between baseline and 6 month
Change in Body Mass Index	Baseline and 6 months	change in body mass index between baseline and 6 month

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States