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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):
George L Bakris, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT00831129
First received: January 26, 2009
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  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: simvastatin
Drug: rosiglitazone
 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:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ]

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: cholesterol lowering drug
zocor
 Drug: simvastatin
dosage is once daily
Other Name: zocor
Active Comparator: sugar-lowering drug 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 Names:
  • Avandia
  • Zocor

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
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: George L Bakris, MD, Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT00831129     History of Changes
Other Study ID Numbers: 14863B (SIROCO)
Study First Received: January 26, 2009
Last Updated: February 27, 2012
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
Anticholesteremic Agents
Simvastatin
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 May 23, 2013