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Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470262
First Posted: May 7, 2007
Last Update Posted: July 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: June 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: Metabolic Syndrome X
Prediabetic State
Interventions: Drug: Fenofibrate 145mg PO QD
Drug: Pioglitazone 45 mg PO QD

  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
Fenofibrate Treatment with fenofibrate 145mg PO QD
Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD Pioglitazone and Fenofibrate: Subjects will be randomized to a combination of both fenofibrate(145mg PO QD) and pioglitazone 45 mg PO QD

Participant Flow:   Overall Study
    Fenofibrate   Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD
STARTED   15   12 
COMPLETED   13   12 
NOT COMPLETED   2   0 
Withdrawal by Subject                2                0 



  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
Fenofibrate 145 mg PO QD Treatment fenofibrate 145 mg PO QD in subjects with pre diabetes
Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD Treatment with Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD in subjects with pre diabetes
Total Total of all reporting groups

Baseline Measures
   Fenofibrate 145 mg PO QD   Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   12   27 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.69  (8.46)   44.67  (11.49)   46.76  (10.03) 
Gender 
[Units: Participants]
     
Female   6   10   16 
Male   9   2   11 
Region of Enrollment 
[Units: Participants]
     
United States   15   12   27 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 34.06  (3.51)   33.93  (3.49)   33.99  (3.43) 


  Outcome Measures
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1.  Primary:   Insulin Sensitivity   [ Time Frame: 3 months ]

2.  Secondary:   IMCL   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


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


Results Point of Contact:  
Name/Title: Dr. Neda Rasouli
Organization: Denver VA Medical Center
phone: 303-399-8020 ext 4314
e-mail: neda.rasouli@ucdenver.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00470262     History of Changes
Other Study ID Numbers: ENDA-020-06S
09-0710 ( Other Identifier: COMIRB )
First Submitted: May 4, 2007
First Posted: May 7, 2007
Results First Submitted: June 27, 2014
Results First Posted: July 21, 2016
Last Update Posted: July 21, 2016