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Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver

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ClinicalTrials.gov Identifier: NCT00323414
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fatty Liver
Interventions Drug: Polyunsaturated fatty acid (Opti-EPA)
Drug: Placebo
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PUFA Placebo
Hide Arm/Group Description Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
Period Title: Overall Study
Started 18 19
Completed 18 18
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title PUFA Placebo Total
Hide Arm/Group Description Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
19
 100.0%
37
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
12
  66.7%
17
  89.5%
29
  78.4%
Male
6
  33.3%
2
  10.5%
8
  21.6%
1.Primary Outcome
Title Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS)
Hide Description The non-alcoholic fatty liver disease (NAFLD) activity score (NAS) is a score based on the liver biopsy. It represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8, with high scores indicating more activity.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Active treatment with PUFA
Placebo arm of therapy
Overall Number of Participants Analyzed 18 19
Measure Type: Count of Participants
Unit of Measure: Participants
8
  44.4%
9
  47.4%
2.Secondary Outcome
Title Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Values
Hide Description Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Active treatment with PUFA
Placebo arm of therapy
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: HOMA-IR index
16.1  (10.3) 13.1  (7.3)
3.Secondary Outcome
Title Aspartate Amino Transferase (AST) Levels
Hide Description Aspartate amino transferase (IU/dL) at 48 weeks
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Active treatment with PUFA
Placebo arm of therapy
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: IU/dL
41.7  (17.4) 47.9  (38.1)
4.Secondary Outcome
Title Alanine Amino Transferase (ALT) Levels
Hide Description Alanine amino transferase (IU/dL) ay 48 weeks
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Active treatment with PUFA
Placebo arm of therapy
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: IU/dL
56.9  (30.9) 59.6  (43.8)
5.Secondary Outcome
Title Blood Glucose Levels
Hide Description Fasting blood glucose
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Active treatment with PUFA
Placebo arm of therapy
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
150.4  (43.7) 123.5  (22.9)
6.Secondary Outcome
Title HbA1C Levels
Hide Description Hemoglobin A1c
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PUFA Placebo
Hide Arm/Group Description:
Active treatment with PUFA
Placebo arm of therapy
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
7.5  (2.2) 6.9  (1.1)
Time Frame 48 weeks
Adverse Event Reporting Description Patient reported adverse events and abnormal laboratory tests were collected
 
Arm/Group Title PUFA Placebo
Hide Arm/Group Description Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
All-Cause Mortality
PUFA Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PUFA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      2/19 (10.53%)    
Surgical and medical procedures     
Post liver biopsy pain  1 [1]  0/18 (0.00%)  0 1/19 (5.26%)  1
Post liver biopsy bleeding  1 [2]  0/18 (0.00%)  0 1/19 (5.26%)  1
1
Term from vocabulary, ICD 9
Indicates events were collected by systematic assessment
[1]
End of treatment, post liver biopsy bleeding requiring blood transfusion in one and none in the other. Both patients showed evidence of perihepatic hematoma and were discharged home uneventfully
[2]
Needed 2 units blood transfusion. Discharged uneventfully and is being followed in the clinic subsequently
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PUFA Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      0/19 (0.00%)    
Surgical and medical procedures     
No tissue  1 [1]  1/18 (5.56%)  1 0/19 (0.00%)  0
1
Term from vocabulary, ICD 9
Indicates events were collected by systematic assessment
[1]
Liver biopsy did not yield tissue
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Srinivasan Dasarathy MD
Organization: Cleveland Clinic Foundation
Phone: 216-444-2766
EMail: dasaras@ccf.org
Layout table for additonal information
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00323414     History of Changes
Other Study ID Numbers: DK61732
U01DK061732 ( U.S. NIH Grant/Contract )
First Submitted: May 5, 2006
First Posted: May 9, 2006
Results First Submitted: August 24, 2017
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018