Phase 3 N=53 Randomized Double-blind

A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Pre-diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00831129 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcome: Primary: Change in High-sensitivity C-reactive Protein — 0.72; -0.61 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rosiglitazone (Drug); Placebo Rosiglitazone (Drug); Simvastatin (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in High-sensitivity C-reactive Protein	0.72; -0.61	—
SECONDARY Change in Urinary Isoprostane	-0.79; -1.09	—
SECONDARY Change in Malondialdehyde	-1.27; -1.52	—
SECONDARY Change in Office Systolic Blood Pressure	-18.24; -16.77	—
SECONDARY Change in Office Diastolic Blood Pressure	-9.59; -9.46	—
SECONDARY Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure	3.41; -1.08	—
SECONDARY Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure	-0.88; -0.69	—
SECONDARY Change in Low-density Lipoprotein	-38.88; -28.77	—
SECONDARY Change in Triglycerides	-34.32; -42.47	—
SECONDARY Change in High-density Lipoprotein	0.71; 2.77	—
SECONDARY Change in Glycosylated Haemoglobin	0.12; -0.22	—
SECONDARY Change in Fasting Blood Glucose	5.94; -4.85	—
SECONDARY Change in Insulin	0.59; -3.47	—
SECONDARY Change in Homeostatic Model Assessment for Insulin Resistance	0.31; -2.08	—
SECONDARY Change in Adiponectin	-0.24; 4.15	—
SECONDARY Change in Body Mass Index	-0.21; 0.68	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00831129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.