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Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation

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ClinicalTrials.gov Identifier: NCT00470262
Recruitment Status : Completed
First Posted : May 7, 2007
Results First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fenofibrate Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD
Hide Arm/Group Description Treatment with 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
Period Title: Overall Study
Started 15 12
Completed 13 12
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Fenofibrate 145 mg PO QD Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD Total
Hide Arm/Group Description Treatment fenofibrate 145 mg PO QD in subjects with pre diabetes Treatment with Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD in subjects with pre diabetes Total of all reporting groups
Overall Number of Baseline Participants 15 12 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 12 participants 27 participants
48.69  (8.46) 44.67  (11.49) 46.76  (10.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Female
6
  40.0%
10
  83.3%
16
  59.3%
Male
9
  60.0%
2
  16.7%
11
  40.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 12 participants 27 participants
15 12 27
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants 12 participants 27 participants
34.06  (3.51) 33.93  (3.49) 33.99  (3.43)
1.Primary Outcome
Title Insulin Sensitivity
Hide Description Insulin sensitivity was measure through frequently sampled intravenous glucose tolerance test. Subjects presented to research center fasting. Blood samples were collected at -21, -11, and -1 minutes. At time t=0 initiates the start of the IVGTT and the injection of glucose into the non-sampling arm. The glucose dose was calculated as 11.4g/m2 of body surface area, given as a 50% dextrose solution. This glucose injection was administered over 60 seconds or less. At time t=20 minutes, an insulin dose of 0.04u/kg was administered over 30 seconds. Blood samples were collected at times t=2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140, 160, and 180. If blood sugar did not return to a steady state the test was continued to t= 210 or t= 240.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fenofibrate 145mg PO QD Fenofibrate 145 mg PO QD + Pioglitazone
Hide Arm/Group Description:
Treatment with fenofibrate in subjects with pre diabetes
Treatment with fenofibrate and pioglitazone in subjects with pre diabetes
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: mg*kg^-1*min^-1
pre 1.48  (0.64) 1.73  (0.75)
post 1.89  (0.88) 2.93  (1.3)
2.Secondary Outcome
Title IMCL
Hide Description Intramyocellular lipid was measured using immunohistochemistry (using oil Red O staining) in muscle biopsy specimens. Oil red O-stained muscle sections were magnified with an Olympus Provis (Tokyo, Japan) light microscope, and images were digitally captured by using a connected charge-coupled device camera (Sony, Tokyo, Japan). Fiber-typed and oil red O-stained fibers were matched. The oil red O staining intensity of either type 1 or 2 muscle fibers was quantified using National Institutes of Health Image program (http://rsb.info.nih.gov/nih-image/). By adjusting a density threshold, the software was set to recognize the presence of one fat droplet only if its highlighted surface was exceeding 0.40 μm2 or larger. Muscle lipid content was calculated by total area of lipid droplets in a given muscle fiber divided by the total area of the same fiber. The mean number of fibers analyzed per sample was 40 for type 1 and 2 muscle fibers
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fenofibrate 145mg PO QD Fenofibrate 145mg PO QD + Pioglitazone 45mg PO BID
Hide Arm/Group Description:
Treatment with fenofibrate in subjects with pre diabetes
Treatment with pioglitazone and fenofibrate in subjects with pre diabetes
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: % of lipid area stained
pre 3.67  (1.30) 5.32  (0.65)
post 3.46  (2.36) 2.82  (0.56)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fenofibrate 145mg PO QD Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD
Hide Arm/Group Description Treatment with fenofibrate 145 mg PO QD in subjects with pre diabetes Treatment with fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD in subjects with pre diabetes
All-Cause Mortality
Fenofibrate 145mg PO QD Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fenofibrate 145mg PO QD Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fenofibrate 145mg PO QD Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      1/12 (8.33%)    
Nervous system disorders     
Syncope * [1]  0/15 (0.00%)  0 1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
unrelated to study medication
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
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