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
Results First Received: June 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Pre-diabetes
Interventions: Drug: 40 mg simvastatin
Drug: Rosiglitazone
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo simvastatin 40 mg/day plus placebo
Rosiglitazone simvastatin 40 mg/day plus rosiglitazone 4 mg/day

Participant Flow:   Overall Study
    Placebo     Rosiglitazone  
STARTED     20     33  
COMPLETED     20     23  
NOT COMPLETED     0     10  
Adverse Event                 0                 1  
9 lost to follow-up reasons uknown                 0                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo simvastatin 40 mg/day plus placebo
Rosiglitazone simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Total Total of all reporting groups

Baseline Measures
    Placebo     Rosiglitazone     Total  
Number of Participants  
[units: participants]
  20     23     43  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 9.3     58.7  ± 12.1     57.03  ± 10.7  
Gender  
[units: participants]
     
Female     6     14     20  
Male     14     9     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in High-sensitivity C-reactive Protein   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Change in Urinary Isoprostane   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Change in Malondialdehyde   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Change in Office Systolic Blood Pressure   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Change in Office Diastolic Blood Pressure   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure   [ Time Frame: Baseline and 6 months ]

7.  Secondary:   Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure   [ Time Frame: Baseline and 6 months ]

8.  Secondary:   Change in Low-density Lipoprotein   [ Time Frame: Baseline and 6 months ]

9.  Secondary:   Change in Triglycerides   [ Time Frame: Baseline and 6 months ]

10.  Secondary:   Change in High-density Lipoprotein   [ Time Frame: Baseline and 6 months ]

11.  Secondary:   Change in Glycosylated Haemoglobin   [ Time Frame: Baseline and 6 months ]

12.  Secondary:   Change in Fasting Blood Glucose   [ Time Frame: Baseline and 6 months ]

13.  Secondary:   Change in Insulin   [ Time Frame: Baseline and 6 months ]

14.  Secondary:   Change in Homeostatic Model Assessment for Insulin Resistance   [ Time Frame: Baseline and 6 months ]

15.  Secondary:   Change in Adiponectin   [ Time Frame: Baseline and 6 months ]

16.  Secondary:   Change in Body Mass Index   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. George Bakris
Organization: University of Chicago
phone: 773-702-7936
e-mail: bbrisky@medicine.bsd.uchicago.edu


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