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A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs (SIROCO)

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ClinicalTrials.gov Identifier: NCT00831129
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : September 12, 2013
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pre-diabetes Drug: Rosiglitazone Drug: Placebo Rosiglitazone Drug: Simvastatin Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.
Study Start Date : September 2006
Primary Completion Date : March 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Simvastatin + Placebo Rosiglitazone
Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily
Drug: Placebo Rosiglitazone
1 tab daily
Other Name: Placebo
Drug: Simvastatin
40 mg daily
Other Name: Zocor
Active Comparator: Simvastatin + rosiglitazone
Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily
Drug: Rosiglitazone
4 mg daily
Other Name: Avandia
Drug: Simvastatin
40 mg daily
Other Name: Zocor



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831129


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
GlaxoSmithKline
Investigators
Principal Investigator: George Bakris, M.D. University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00831129     History of Changes
Other Study ID Numbers: 14863B (SIROCO)
First Posted: January 28, 2009    Key Record Dates
Results First Posted: September 12, 2013
Last Update Posted: February 10, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Simvastatin
Rosiglitazone
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs