Status:
COMPLETED
Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Fatty Liver
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Non-alcoholic steatohepatitis (NASH), the most severe form of liver injury in the spectrum of non-alcoholic fatty liver disease (NAFLD), has emerged as the major cause of chronic liver disease in deve...
Detailed Description
Although there is no proven effective treatment of NASH, dietary supplementation with long chain omega-3 polyunsaturated fatty acids (PUFA's) may be beneficial. This suggestion is based on three previ...
Eligibility Criteria
Inclusion
- Adult patients (age \>18 years)
- Have type 2 diabetes mellitus with good control of blood sugar (hemoglobin A1c \[HbA1c\] \<7.5%) and will have been on a stable regimen of anti-diabetic agents for more than 4 months.
- NASH established on liver biopsy done within 6 months prior to inclusion in the study as determined by established histologic criteria
Exclusion
- Cirrhosis of the liver
- End stage target organ damage in diabetes mellitus: advanced renal failure (serum creatinine \> 2.0 mg/dl) with or without dialysis, severe neuropathy, or advanced peripheral vascular disease.
- Any organ dysfunction with anticipated life expectancy of less than 2 years
- Co-existent etiologies for liver disease
- Significant alcohol consumption, defined as more than 30 g per day in men and more than 20 g per day in women.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00323414
Start Date
April 1 2006
End Date
December 1 2011
Last Update
February 23 2018
Active Locations (2)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
2
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195