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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
PUFA Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks
Placebo Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks

Participant Flow:   Overall Study
    PUFA   Placebo
STARTED   18   19 
COMPLETED   18   18 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
PUFA Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks
Placebo Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
Total Total of all reporting groups

Baseline Measures
   PUFA   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   19   37 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      12  66.7%      17  89.5%      29  78.4% 
Male      6  33.3%      2  10.5%      8  21.6% 


  Outcome Measures

1.  Primary:   Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS)   [ Time Frame: 48 weeks ]

2.  Secondary:   Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Values   [ Time Frame: 48 weeks ]

3.  Secondary:   Aspartate Amino Transferase (AST) Levels   [ Time Frame: 48 weeks ]

4.  Secondary:   Alanine Amino Transferase (ALT) Levels   [ Time Frame: 48 weeks ]

5.  Secondary:   Blood Glucose Levels   [ Time Frame: 48 weeks ]

6.  Secondary:   HbA1C Levels   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Srinivasan Dasarathy MD
Organization: Cleveland Clinic Foundation
phone: 216-444-2766
e-mail: dasaras@ccf.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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