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Completed

NCT Number: NCT00831129

A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

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.

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Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

4 mg daily

Other names: Avandia

Placebo Rosiglitazone

Drug

1 tab daily

Other names: Placebo

simvastatin

Drug

40 mg daily

Other names: Zocor

Primary outcomes

  1. Change in High-sensitivity C-reactive Protein

    Time frame: Baseline and 6 months

    change in high-sensitivity C-reactive between baseline and 6 month

Secondary outcomes

  1. Change in Urinary Isoprostane

    Time frame: Baseline and 6 months

    change in urinary isoprostane between baseline and 6 month

  2. Change in Malondialdehyde

    Time frame: Baseline and 6 months

    change in Malondialdehyde between baseline and 6 month

  3. Change in Office Systolic Blood Pressure

    Time frame: Baseline and 6 months

    change in office systolic blood pressure between baseline and 6 month

  4. Change in Office Diastolic Blood Pressure

    Time frame: Baseline and 6 months

    change in office diastolic blood pressure between baseline and 6 month

  5. Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure

    Time frame: Baseline and 6 months

    change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month

  6. Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure

    Time frame: Baseline and 6 months

    change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month

  7. Change in Low-density Lipoprotein

    Time frame: Baseline and 6 months

    change in low-density lipoprotein between baseline and 6 month

  8. Change in Triglycerides

    Time frame: Baseline and 6 months

    change in Triglycerides between baseline and 6 month

  9. Change in High-density Lipoprotein

    Time frame: Baseline and 6 months

    change in high-density lipoprotein between baseline and 6 month

  10. Change in Glycosylated Haemoglobin

    Time frame: Baseline and 6 months

    change in glycosylated haemoglobin between baseline and 6 month

  11. Change in Fasting Blood Glucose

    Time frame: Baseline and 6 months

    change in fasting blood glucose between baseline and 6 month

  12. Change in Insulin

    Time frame: Baseline and 6 months

    change in Insulin between baseline and 6 month

  13. Change in Homeostatic Model Assessment for Insulin Resistance

    Time frame: Baseline and 6 months

    change in homeostatic model assessment for insulin resistance between baseline and 6 month

  14. Change in Adiponectin

    Time frame: Baseline and 6 months

    change in Adiponectin between baseline and 6 month

  15. Change in Body Mass Index

    Time frame: Baseline and 6 months

    change in body mass index between baseline and 6 month

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.

Acronym: SIROCO

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 28, 2009
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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