| Trial ID: | L3498 |
| Source ID: | NCT00323414
|
| Associated Drug: |
Polyunsaturated Fatty Acid (Opti-Epa)
|
| Title: |
Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00323414/results
|
| Conditions: |
Fatty Liver
|
| Interventions: |
DRUG: Polyunsaturated fatty acid (Opti-EPA)|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS), 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., 48 weeks | Secondary: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Values, 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., 48 weeks|Aspartate Amino Transferase (AST) Levels, Aspartate amino transferase (IU/dL) at 48 weeks, 48 weeks|Alanine Amino Transferase (ALT) Levels, Alanine amino transferase (IU/dL) ay 48 weeks, 48 weeks|Blood Glucose Levels, Fasting blood glucose, 48 weeks|HbA1C Levels, Hemoglobin A1c, 48 weeks
|
| Sponsor/Collaborators: |
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
37
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-04
|
| Completion Date: |
2011-12
|
| Results First Posted: |
2018-02-23
|
| Last Update Posted: |
2018-02-23
|
| Locations: |
MetroHealth Medical Center, Cleveland, Ohio, 44109, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00323414
|
