A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Pre-diabetes Clinical Trial

— SIROCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831129
• Other study ID #: 14863B (SIROCO)
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 26, 2009
• Last updated: September 16, 2013
• Start date: September 2006
• Est. completion date: April 2011

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Pre-diabetes

Intervention

Drug:
• 40 mg simvastatin
dosage is once daily
• 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:
• 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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in High-sensitivity C-reactive Protein	change in high-sensitivity C-reactive between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Urinary Isoprostane	change in urinary isoprostane between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Malondialdehyde	change in Malondialdehyde between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Office Systolic Blood Pressure	change in office systolic blood pressure between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Office Diastolic Blood Pressure	change in office diastolic blood pressure between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure	change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure	change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Low-density Lipoprotein	change in low-density lipoprotein between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Triglycerides	change in Triglycerides between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in High-density Lipoprotein	change in high-density lipoprotein between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Glycosylated Haemoglobin	change in glycosylated haemoglobin between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Fasting Blood Glucose	change in fasting blood glucose between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Insulin	change in Insulin between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Homeostatic Model Assessment for Insulin Resistance	change in homeostatic model assessment for insulin resistance between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Adiponectin	change in Adiponectin between baseline and 6 month	Baseline and 6 months	No
Secondary	Change in Body Mass Index	change in body mass index between baseline and 6 month	Baseline and 6 months	No