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Pre-diabetesPhase 2/3SIROCONCT00831129

A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

A Phase 2/3 study testing Rosiglitazone and Simvastatin in people with Pre-diabetes, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Pre-diabetes
What is being tested?
Rosiglitazone and Simvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteUnited States
Study dates
Sep 2006to Apr 2011
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: 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.

Read the 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

Conditions
Pre-diabetes
Being tested
Rosiglitazone, Placebo Rosiglitazone, Simvastatin
Medical subject headings
Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosiglitazoneDrug

    Also called Avandia

    4 mg daily

  • Placebo RosiglitazoneDrug

    Also called Placebo

    1 tab daily

  • SimvastatinDrug

    Also called Zocor

    40 mg daily

Study groups in NCT00831129
Study groupRoleWhat they receive
Simvastatin + Placebo RosiglitazoneActive comparatorSubjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily
Receives: Drug: Placebo Rosiglitazone; Drug: Simvastatin
Simvastatin + rosiglitazoneActive comparatorSubjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily
Receives: Drug: Rosiglitazone; Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in High-sensitivity C-reactive Protein

    change in high-sensitivity C-reactive between baseline and 6 month

    Measured: Baseline and 6 months

Secondary outcomes (15)

  1. Change in Urinary Isoprostane

    change in urinary isoprostane between baseline and 6 month

    Measured: Baseline and 6 months

  2. Change in Malondialdehyde

    change in Malondialdehyde between baseline and 6 month

    Measured: Baseline and 6 months

  3. Change in Office Systolic Blood Pressure

    change in office systolic blood pressure between baseline and 6 month

    Measured: Baseline and 6 months

  4. Change in Office Diastolic Blood Pressure

    change in office diastolic blood pressure between baseline and 6 month

    Measured: Baseline and 6 months

  5. Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure

    change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month

    Measured: Baseline and 6 months

  6. Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure

    change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month

    Measured: Baseline and 6 months

  7. Change in Low-density Lipoprotein

    change in low-density lipoprotein between baseline and 6 month

    Measured: Baseline and 6 months

  8. Change in Triglycerides

    change in Triglycerides between baseline and 6 month

    Measured: Baseline and 6 months

  9. Change in High-density Lipoprotein

    change in high-density lipoprotein between baseline and 6 month

    Measured: Baseline and 6 months

  10. Change in Glycosylated Haemoglobin

    change in glycosylated haemoglobin between baseline and 6 month

    Measured: Baseline and 6 months

  11. Change in Fasting Blood Glucose

    change in fasting blood glucose between baseline and 6 month

    Measured: Baseline and 6 months

  12. Change in Insulin

    change in Insulin between baseline and 6 month

    Measured: Baseline and 6 months

  13. Change in Homeostatic Model Assessment for Insulin Resistance

    change in homeostatic model assessment for insulin resistance between baseline and 6 month

    Measured: Baseline and 6 months

  14. Change in Adiponectin

    change in Adiponectin between baseline and 6 month

    Measured: Baseline and 6 months

  15. Change in Body Mass Index

    change in body mass index between baseline and 6 month

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2009 (estimated)
  2. Study startSep 2006
  3. Primary completionMar 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00831129
Sponsor's protocol ID
14863B (SIROCO)
Acronym
SIROCO
Status last verified
Dec 2016
First submitted
26 Jan 2009
Last updated
10 Feb 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rosiglitazone and Simvastatin in people with Pre-diabetes, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in High-sensitivity C-reactive Protein (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00831129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.

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