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Insulin Resistance in Non-alcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT01289639
Recruitment Status : Terminated (Low recruitment in intervention study. Baseline data published.)
First Posted : February 4, 2011
Results First Posted : October 20, 2014
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Fatty Liver
Interventions Drug: fenofibrate
Drug: pioglitazone
Drug: placebo
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description

matching placebo for fenofibrate 1 capsule po qd

matching placebo for pioglitazone 1 capsule po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

Period Title: Overall Study
Started 5 6 0
Completed 4 6 0
Not Completed 1 0 0
Reason Not Completed
Lost to Follow-up             1             0             0
Arm/Group Title Arm 1 Arm 2 Arm 3 Total
Hide Arm/Group Description

matching placebo for fenofibrate 1 po qd

matching placebo for pioglitazone 1 po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

Total of all reporting groups
Overall Number of Baseline Participants 5 6 0 11
Hide Baseline Analysis Population Description
Subjects recruited with known NAFLD or NASH.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 0 participants 11 participants
49.2  (7.3) 54.17  (5.08) 51.91  (6.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 0 participants 11 participants
Female
2
  40.0%
2
  33.3%
4
  36.4%
Male
3
  60.0%
4
  66.7%
7
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 0 participants 11 participants
5 6 11
1.Primary Outcome
Title Liver/Spleen Ratio Measured as the Ratio in Hounsfield Units Between the Liver and the Spleen on Computed Tomography (CT) Scan
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

matching placebo for fenofibrate 1 capsule po qd

matching placebo for pioglitazone 1 capsule po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

Overall Number of Participants Analyzed 4 6 0
Mean (Standard Error)
Unit of Measure: ratio
.85  (.08) .60  (.17)
2.Secondary Outcome
Title Change in Alanine Aminotransferase (ALT) Levels
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

matching placebo for fenofibrate 1 capsule po qd

matching placebo for pioglitazone 1 capsule po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

Overall Number of Participants Analyzed 4 6 0
Mean (Standard Error)
Unit of Measure: U/L
-11.5  (12.9) -15.2  (4.5)
3.Secondary Outcome
Title Change in Liver/Spleen Ratio Measure by the Density Ratio in Hounsfield Units Between the Liver and the Spleen by CT
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

matching placebo for fenofibrate 1 capsule po qd

matching placebo for pioglitazone 1 capsule po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

Overall Number of Participants Analyzed 4 6 0
Mean (Standard Error)
Unit of Measure: ratio
.09  (.10) -0.16  (0.1)
4.Secondary Outcome
Title Change in Peripheral Insulin Sensitivity
Hide Description Change in the rate of glucose disposal (Rd) during the low dose clamp. During a clamp procedure, insulin is infused at a dose based on body size and a glucose solution is infused and the rate adjusted every 5 minutes based on a blood glucose reading to maintain the blood glucose stable at 90 mg/dl (normal level). Using glucose isotopes and the rate of the glucose infusion, we are then able to calculate how much glucose the liver is producing and how much glucose is being taken up into tissues. This provides a measure of insulin sensitivity.
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

matching placebo for fenofibrate 1 capsule po qd

matching placebo for pioglitazone 1 capsule po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

Overall Number of Participants Analyzed 4 5 0
Mean (Standard Error)
Unit of Measure: mg/minute/kg lean mass
0.21  (0.51) -0.42  (0.49)
5.Secondary Outcome
Title Change in Intra-abdominal Fat Area by CT Scan
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

matching placebo for fenofibrate 1 capsule po qd

matching placebo for pioglitazone 1 capsule po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

Overall Number of Participants Analyzed 4 6 0
Mean (Standard Error)
Unit of Measure: mm2
885  (874) 108  (3416)
6.Secondary Outcome
Title Change in Hepatic Insulin Sensitivity
Hide Description Hepatic insulin sensitivity was determined using stable glucose isotope measurements during the low dose hyperinsulinemic euglycemic clamp to determine the rate of endogenous glucose production in the fasting state and in response to a low dose glucose infusion. The ability of insulin to suppress glucose, which is mainly produced by the liver, thus provides a measure of hepatic insulin sensitivity and is expressed as a percentage of the basal state. Change in the ability of low dose insulin to suppress endogenous glucose production during a labeled hyperinsulinemic euglycemic clamp.
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

matching placebo for fenofibrate 1 capsule po qd

matching placebo for pioglitazone 1 capsule po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

Overall Number of Participants Analyzed 4 5 0
Mean (Standard Error)
Unit of Measure: % change from baseline
23.3  (7.8) 4.9  (9.3)
Time Frame Baseline and monthly.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description

matching placebo for fenofibrate 1 capsule po qd

matching placebo for pioglitazone 1 capsule po qd

micronized fenofibrate 200 mg 1 po qd

matching placebo for pioglitazone 1 po qd

pioglitazone 30 mg po qd

matching placebo for fenofibrate 1 po qd

All-Cause Mortality
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/6 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      4/6 (66.67%)      0/0    
Blood and lymphatic system disorders       
leg edema *  0/5 (0.00%)  0 2/6 (33.33%)  2 0/0  0
General disorders       
vasovagal reaction *  2/5 (40.00%)  2 0/6 (0.00%)  0 0/0  0
Musculoskeletal and connective tissue disorders       
gout attack *  1/5 (20.00%)  1 2/6 (33.33%)  3 0/0  0
Renal and urinary disorders       
increased serum creatinine   0/5 (0.00%)  0 2/6 (33.33%)  2 0/0  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Due to low enrollment, the study was stopped prematurely. Due to the low number of subjects enrolled, statistical analysis was not possible on the intervention study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kristina Utzschneider
Organization: VA Puget Sound Health Care System
Phone: 206-277-3568 ext 6-3568
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01289639     History of Changes
Other Study ID Numbers: CDA-2-044-08S-2
First Submitted: January 21, 2011
First Posted: February 4, 2011
Results First Submitted: October 1, 2014
Results First Posted: October 20, 2014
Last Update Posted: August 17, 2017