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Obesity and Nonalcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT00262964
Recruitment Status : Completed
First Posted : December 7, 2005
Results First Posted : June 28, 2010
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Non-alcoholic Fatty Liver Disease
Interventions Drug: Niacin
Drug: fenofibrate
Drug: placebo
Enrollment 51
Recruitment Details Beginning and ending recruitment dates: Beginning – 10/20/04; Ending – 09/24/07. Recruitment occurred only at Washington University in St. Louis.
Pre-assignment Details We screened 138 subjects. 80 would-be participants failed the screening. This was often due to not having Non-alcoholic Fatty Liver Disease. Other subjects were excluded due to use of various medications or the presence of some excluded disease such as type 2 diabetes. Of the 58 that passed screening 51 chose to enroll in the study.
Arm/Group Title NAFLD - Niacin NAFLD - Fenofibrate Controls NAFLD - no Drug
Hide Arm/Group Description subjects diagnosed with NAFLD were randomized to a sixteen week regimen of niacin. Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate Subjects with normal intrahepatic fat triglyceride(IHTG) levels (<10%). IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0. Subjects with elevated intrahepatic triglyceride (IHTG) levels (>10%) who were measured only once (baseline). These subjects did not undergo drug therapy, in contrast to the NAFLD-niacin and NAFLD-fenofibrate group subjects. IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
Period Title: Overall Study
Started 11 11 17 12
Completed 11 11 17 12
Not Completed 0 0 0 0
Arm/Group Title Controls NAFLD Total
Hide Arm/Group Description Subjects with normal intra-hepatic triglyceride content (defined by less than 10% lipid to water signal in magnetic resonance spectroscopy). Subjects diagnosed with Non-Alcoholic Fatty Liver Disease(NAFLD). Determination of NAFLD was by magnetic resonance spectroscopy of intra-hepatic triglyceride content (defined by greater than 10% lipid to water signal). This group included subjects later randomized into the NAFLD-Niacin, NAFLD-Fenofibrate, and NAFLD-no intervention arms. Total of all reporting groups
Overall Number of Baseline Participants 17 34 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants 34 participants 51 participants
<=18 years 0 0 0
Between 18 and 65 years 17 34 51
>=65 years 0 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 34 participants 51 participants
41  (3) 45  (3) 42  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 34 participants 51 participants
Female
13
  76.5%
24
  70.6%
37
  72.5%
Male
4
  23.5%
10
  29.4%
14
  27.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 34 participants 51 participants
17 34 51
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 17 participants 34 participants 51 participants
35.11  (4.33) 36.73  (4.66) 36.19  (4.57)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 17 participants 34 participants 51 participants
99.8  (11.6) 104.1  (15.6) 102.7  (14.4)
fat as percentage of total body composition   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total body weight
Number Analyzed 17 participants 34 participants 51 participants
42.1  (6.9) 39.3  (6.0) 40.3  (6.4)
[1]
Measure Description: fat as percentage of total body composition as characterized using whole body Dual Energy X-ray Absorptiometry (DEXA).
plasma glucose level   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 17 participants 34 participants 51 participants
94.2  (6.0) 96.0  (8.6) 95.4  (7.8)
[1]
Measure Description: fasting plasma glucose level
plasma insulin level   [1] 
Mean (Standard Deviation)
Unit of measure:  mU/L
Number Analyzed 17 participants 34 participants 51 participants
11.4  (4.5) 21.2  (9.9) 17.9  (9.6)
[1]
Measure Description: fasting plasma insulin
1.Primary Outcome
Title Hepatic Insulin Sensitivity Index (HISI)
Hide Description Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index(HISI) is the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.
Time Frame baseline cross-sectional data
Hide Outcome Measure Data
Hide Analysis Population Description
number of subjects determined by power calculations. Analysis was per protocol. Intrahepatic triglyceride was determined by magnetic resonance spectroscopy.
Arm/Group Title NAFLD Controls
Hide Arm/Group Description:
subjects with intra-hepatic triglyceride content greater than 10%.
subjects with normal intra-hepatic triglyceride levels
Overall Number of Participants Analyzed 34 17
Mean (Standard Error)
Unit of Measure: [10000/(μmol/min)x(mU/L)]
0.8  (0.14) 1.4  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD, Controls
Comments null hypothesis was no difference in hepatic insulin sensitivity between normal and high IHTG subjects
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.019
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Percent Increase in Skeletal Muscle Insulin Sensitivity During Insulin Infusion.
Hide Description A precise measure of the ability of insulin to stimulate glucose uptake by skeletal muscle. Skeletal muscle insulin sensitivity, measured as the increase from baseline in skeletal muscle glucose uptake during insulin infusion(percentage)as part of a nine hour euglycemic hyperinsulinemic clamp study.
Time Frame baseline cross-sectional data pre and post nine hour euglycemic clamp
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD Controls
Hide Arm/Group Description:
Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy
subjects with normal levels of intra-hepatic trigleceride
Overall Number of Participants Analyzed 34 17
Mean (Standard Error)
Unit of Measure: percent increase
173  (13) 303  (23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD, Controls
Comments null hypothesis was no difference in skeletal muscle insulin sensitivity between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments a priori threshold for significance was set at p = 0.05.
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Adipose Tissue Insulin Sensitivity
Hide Description The ability of insulin to suppress the release of fatty acids from adipose tissue: Adipose tissue insulin sensitivity, measured as the suppression from baseline of free fatty acid release from adipose tissue (lipolysis) during insulin infusion as part of a nine hour euglycemic hyperinsulinemic clamp study.
Time Frame baseline cross-sectional data pre and post nine hour euglycemic clamp
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD Controls
Hide Arm/Group Description:
Subjects with elevated intrahepatic triglyceride (>10% signal compared to H2O) measured by MR Spectroscopy.
subjects with normal intrahepatic triglyceride levels
Overall Number of Participants Analyzed 34 17
Mean (Standard Error)
Unit of Measure: percent decrease
66  (2) 75  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD, Controls
Comments null hypothesis was that there would be no difference in adipose tissue insulin sensitivity due to IHTG levels.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Hepatic Fat Content for Fenofibrate and Niacin Groups
Hide Description Hepatic fat content as measured by magnetic resonance spectroscopy. A PRESS sequence was used. The results from three 10 cubic centimeter voxels positioned within the liver were averaged. The measure is a ratio of triglyceride signal to total signal.
Time Frame baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)
Hide Outcome Measure Data
Hide Analysis Population Description
10 (or more) subjects in each group would be sufficient for detecting changes in IHTG.
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin
Hide Arm/Group Description:
Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
subjects given niacin for 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline 23.2  (10.2) 21.0  (10.4)
8 wk (fenofibrate), 16 wk (niacin) 23.6  (11.2) 19.7  (8.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD - Fenofibrate
Comments Student’s t-test for paired samples was used to evaluate any difference between the two groups. The null hypothesis was that the IHTG percentage would be the same before and after treatment for subjects receiving fenofibrate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .301
Comments A P-value < 0.05 was considered statistically significant.
Method t-test, 2 sided
Comments Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student’s t-test was used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAFLD - Niacin
Comments A Student’s t-test for paired samples was used to evaluate the effect of treatment. The null hypothesis was that the IHTG percentage for the NAFLD-niacin group at baseline and post-treatment would not change.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .315
Comments A P-value < 0.05 was considered statistically significant.
Method t-test, 2 sided
Comments Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student’s t-test was used.
5.Primary Outcome
Title Adipose Tissue Insulin Sensitivity in Fenofibrate and Niacin Groups
Hide Description The baseline and post-treatment measures of adipose tissue insulin sensitivity (ATIS) were compared. ATIS at both timepoints is the suppression from fasting levels of free fatty acid release from adipose tissue (lipolysis) during an insulin infusion as part of a euglycemic clamp study. It is the percent decrease from time zero to the end of the nine hour euglycemic hyperinsulinemic clamp
Time Frame baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin
Hide Arm/Group Description:
Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
subjects given niacin for 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: percent decrease
Baseline 68  (4) 63  (4)
8 weeks (fenofibrate) or 16 weeks (niacin) 69  (2) 35  (10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD - Fenofibrate
Comments Null hypothesis was that fenofibrate would not affect adipose tissue insulin sensitivity. We compare the baseline and post-treatment results for adipose tissue insulin sensitivity in the subjects who received fenofibrate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .768
Comments A priori threshold for significance was set for p<0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAFLD - Niacin
Comments Null hypothesis was that niacin would not affect adipose tissue insulin sensitivity. Here we compare the baseline and post-treatment adipose tissue insulin sensitivity results for subjects who received a 16 week course of niacin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .019
Comments A priori threshold for significance was set for p<0.05.
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline in Skeletal Muscle Insulin Sensitivity
Hide Description Changes in skeletal muscle insulin sensitivity (SMIS). SMIS was measured as the increase in skeletal muscle glucose uptake from time zero to the end of a nine hour euglycemic clamp and insulin infusion study. This increase is the percentage change from time zero to end of insulin infusion at nine hours.
Time Frame baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin
Hide Arm/Group Description:
Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
subjects given niacin for 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: percent increase
Baseline 188  (36) 183  (22)
8 weeks (fenofibrate) or 16 weeks (niacin) 169  (28) 142  (26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD - Fenofibrate
Comments The null hypothesis was that fenofibrate would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results in subjects receiving an 8 week course of fenofibrate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .318
Comments The a priori threshold for significance was set at p<0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAFLD - Niacin
Comments The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results for subjects receiving a 16 week course of niacin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .025
Comments The a priori threshold for significance was set at p<0.05.
Method t-test, 2 sided
Comments [Not Specified]
7.Primary Outcome
Title Change From Baseline in Hepatic Insulin Sensitivity Index
Hide Description Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index (HISI) is measured as the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.
Time Frame baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin
Hide Arm/Group Description:
Subjects with elevated intrahepatic triglyceride given an eight week course of fenofibrate
subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: [10000/(μmol/min)x(mU/L)]
Baseline 0.7  (0.1) 0.8  (0.4)
8 weeks (fenofibrate) or 16 weeks (niacin) 0.8  (0.1) 0.5  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD - Fenofibrate
Comments The null hypothesis was that fenofibrate would not affect hepatic insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .419
Comments The a priori threshold for significance was set at p<0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAFLD - Niacin
Comments The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .018
Comments The a priori threshold for significance was set at p<0.05.
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Very Low Density Lipoprotein - Triglyceride Production Rate
Hide Description Very low density lipoprotein triglyceride (VLDL-TG) production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute (μmol/L/min).
Time Frame baseline cross-sectional data
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD Controls
Hide Arm/Group Description:
Subjects with intrahepatic triglyceride content greater than 10% per Magnetic Resonance Spectroscopy
subjects with normal levels of intra-hepatic trigleceride
Overall Number of Participants Analyzed 34 17
Mean (Standard Error)
Unit of Measure: μmol/L/min
6.7  (0.5) 3.8  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD, Controls
Comments null hypothesis was that VLDL-TG production would not differ between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments a priori threshold for significance was P<0.05.
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Very Low Density Lipoprotein Apolipoprotein B Production Rate
Hide Description VLDL-apolipoprotein B (apoB) concentrations were measured as part of a VLDL metabolism study utilizing stable isotope tracers. VLDL apoB production rate, a measure of hepatic secretion of VLDL-apolipoproteinB-100 per liter of plasma per minute.
Time Frame baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin
Hide Arm/Group Description:
Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
subjects given Niacin for 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: nmol/l/min
Baseline 0.5  (0.05) 0.4  (0.04)
8 wk (fenofibrate), 16 wk (niacin) 0.4  (0.05) 0.4  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD - Niacin
Comments a Student’s t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 16 weeks on niacin in subjects with NAFLD.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments A P-value < 0.05 was considered statistically significant.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAFLD - Fenofibrate
Comments A Student’s t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 8 weeks on fenofibrate in subjects with NAFLD.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .022
Comments A P-value < 0.05 was considered statistically significant.
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in VLDL-Tg Clearance Rate
Hide Description Very low density lipoprotein triglyceride (VLDL-Tg) clearance rate, a measure of VLDL-triglyceride removal from plasma per minute.
Time Frame baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin
Hide Arm/Group Description:
Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy given an eight week course of fenofibrate
subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: (ml/min)
Baseline 35  (9) 34  (8)
8 weeks (fenofibrate) or 16 weeks (niacin) 56  (12) 52  (23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD - Fenofibrate
Comments the null hypothesis was that fenofibrate would not change the VLDL-Tg clearance rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .020
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAFLD - Niacin
Comments the null hypothesis was that niacin would not change the VLDL-Tg clearance rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .358
Comments a priori threshold for significance was <0.05.
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in VLDL-Tg Production Rate
Hide Description VLDL-TG production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute.
Time Frame baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin
Hide Arm/Group Description:
Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy receiving fenofibrate for eight weeks.
subjects with elevated levels of intra-hepatic trigleceride (>10% signal by MR spectroscopy) given a 16 week course of niacin
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: (μmol/L/min)
Baseline 6.4  (0.7) 7.7  (1.6)
8 weeks (fenofibrate) or 16 weeks (niacin) 6.0  (0.6) 4.5  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD - Fenofibrate
Comments Null hypothesis is that fenofibrate would not effect VLDL-Tg production rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.758
Comments a priori threshold for statistical significance was set at <0.05.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAFLD - Niacin
Comments Null hypothesis is that niacin would not effect VLDL-Tg production rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .023
Comments the a priori threshold for statistical significance was set at <0.05.
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Very Low-density Lipoprotein Triglyceride Concentration
Hide Description Change from baseline in very low-density lipoprotein triglyceride concentration (VLDL-Tg)
Time Frame baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin
Hide Arm/Group Description:
Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
subjects given Niacin for 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: mmol/l
Baseline 1.09  (0.28) 1.04  (0.24)
8 weeks (fenofibrate) or 16 weeks (niacin) 0.50  (0.10) 0.64  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFLD - Fenofibrate
Comments Null hypothesis was that fenofibrate would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .024
Comments the a priori threshold for statistical significance was p <0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NAFLD - Niacin
Comments The null hypothesis was that niacin would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments the a priori threshold for statistical significance was p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse event data was collected from baseline testing through post-treatment testing. The "NAFLD - no drug" and control groups were only followed through the baseline testing.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NAFLD - Fenofibrate NAFLD - Niacin NAFLD - no Drug Controls
Hide Arm/Group Description Subjects diagnosed with NAFLD were randomized to an weight week regimen of fenofibrate subjects with intra-hepatic triglyceride signal greater than 10% placed on daily niacin for 16 weeks. The dose of medication will be gradually increased according to the protocol of most clinical trials (59): 500 mg/day during wk 1, 1000 mg/day during wk 2, 1500 mg/day during wks 3, and 2000mg/day during wks 4-16. subjects with elevated hepatic triglyceride who did not receive any drug intervention subjects with normal hepatic triglyceride.
All-Cause Mortality
NAFLD - Fenofibrate NAFLD - Niacin NAFLD - no Drug Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NAFLD - Fenofibrate NAFLD - Niacin NAFLD - no Drug Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)      0/12 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
NAFLD - Fenofibrate NAFLD - Niacin NAFLD - no Drug Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/11 (0.00%)      0/12 (0.00%)      0/17 (0.00%)    
Hepatobiliary disorders         
elevation of liver enzymes  [1]  1/11 (9.09%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
assessment of liver dysfunction by ALT and/or AST counts in blood plasma
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elisa Fabbrini, MD
Organization: Washington University School of Medicine
Phone: 314-362-8156
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00262964     History of Changes
Other Study ID Numbers: DK37948
R01DK037948 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2005
First Posted: December 7, 2005
Results First Submitted: March 15, 2010
Results First Posted: June 28, 2010
Last Update Posted: July 11, 2018