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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00831129
First received: January 26, 2009
Last updated: September 16, 2013
Last verified: September 2013

January 26, 2009
September 16, 2013
September 2006
March 2011   (final data collection date for primary outcome measure)
Change in High-sensitivity C-reactive Protein [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
change in high-sensitivity C-reactive between baseline and 6 month
Doctors do not know if giving these drugs together would result in even greater improvement in related risk factors (high blood pressure, diabetes) than the administration of each drug alone. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00831129 on ClinicalTrials.gov Archive Site
  • Change in Urinary Isoprostane [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in urinary isoprostane between baseline and 6 month
  • Change in Malondialdehyde [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in Malondialdehyde between baseline and 6 month
  • Change in Office Systolic Blood Pressure [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in office systolic blood pressure between baseline and 6 month
  • Change in Office Diastolic Blood Pressure [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in office diastolic blood pressure between baseline and 6 month
  • Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month
  • Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month
  • Change in Low-density Lipoprotein [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in low-density lipoprotein between baseline and 6 month
  • Change in Triglycerides [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in Triglycerides between baseline and 6 month
  • Change in High-density Lipoprotein [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in high-density lipoprotein between baseline and 6 month
  • Change in Glycosylated Haemoglobin [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in glycosylated haemoglobin between baseline and 6 month
  • Change in Fasting Blood Glucose [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in fasting blood glucose between baseline and 6 month
  • Change in Insulin [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in Insulin between baseline and 6 month
  • Change in Homeostatic Model Assessment for Insulin Resistance [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in homeostatic model assessment for insulin resistance between baseline and 6 month
  • Change in Adiponectin [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in Adiponectin between baseline and 6 month
  • Change in Body Mass Index [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change in body mass index between baseline and 6 month
Not Provided
Not Provided
Not Provided
 
A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs
Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.

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.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Pre-diabetes
  • Drug: 40 mg simvastatin
    dosage is once daily
    Other Name: zocor
  • Drug: Rosiglitazone
    Subjects will either receive Simvastatin 40mg once daily plus Rosiglitazone at 4mg once daily or Simvastatin 40mg once daily plus placebo 1 tab daily
    Other Name: Avandia
  • Other: Placebo
    Subjects will either receive Simvastatin 40mg once daily plus Rosiglitazone at 4mg once daily or Simvastatin 40mg once daily plus placebo 1 tab daily
  • Active Comparator: Simvastatin + placebo
    Subjects will either receive Simvastatin 40mg once daily plus Rosiglitazone at 4mg once daily or Simvastatin 40mg once daily plus placebo 1 tab daily
    Interventions:
    • Drug: 40 mg simvastatin
    • Other: Placebo
  • Active Comparator: Simvastatin + rosiglitazone
    40 mg simvastatin and 4 mg rosiglitazone one time per day
    Interventions:
    • Drug: 40 mg simvastatin
    • Drug: Rosiglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
April 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00831129
14863B (SIROCO)
No
University of Chicago
University of Chicago
GlaxoSmithKline
Principal Investigator: George Bakris, M.D. University of Chicago
University of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP