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
  Purpose

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 Intervention Phase
Pre-diabetes
Drug: 40 mg simvastatin
Drug: Rosiglitazone
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 53
Study Start Date: September 2006
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: 40 mg simvastatin
dosage is once daily
Other Name: zocor
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 + rosiglitazone
40 mg simvastatin and 4 mg rosiglitazone one time per day
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

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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00831129     History of Changes
Other Study ID Numbers: 14863B (SIROCO)
Study First Received: January 26, 2009
Results First Received: June 27, 2013
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014