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NCT00323414 · ClinicalTrials.gov registry record · Phase 2
Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver
A Phase 2 study of Fatty Liver, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT00323414 is a Phase 2 study of Fatty Liver that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 37 participants, below the 209-participant average among 20 other Fatty Liver trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00323414, a Phase 2 study of Fatty Liver, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study 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 developed countries. Among adults in the United States, the prevalence is between 5.7% and 17%. These rates are expected to increase concurrent with the epidemics of obesity and type 2 diabetes mellitus, which are the major risk factors for NAFLD and NASH. In addition to its high prevalence, NASH is also a progressive fibrotic disease that advances to cirrhosis and liver related death in 20% and 12% of patients, respectively. Among NASH patients with cirrhosis, 40% have liver related death. Diabetics are particularly prone to experience these poor outcomes. No therapy has been proven effective for patients with NASH. The purpose of this study is to find out whether treatment with polyunsaturated fatty acids (eicosapentaenoic acid \[EPA\] combined with docosahexaenoic acid \[DHA\] called Opti-EPA) improves NASH compared to treatment with placebo pills. The placebo pills will contain corn oil and will be contained in a capsule, but have no medical effect on the body. The investigators will determine improvement in NASH from microscopic changes in the subject's liver tissue during 48 weeks of treatment. This means that the subject will need to have a liver biopsy before and after the treatment. Omega-3 fatty acids are a form of polyunsaturated fats, one of the four basic types of fat that the body gets from food. (Cholesterol, saturated fat, and monounsaturated fat are the others.) One's body does not make this type of fat; it comes from food sources. These fats are found in foods like cold water fish (tuna, salmon, and mackerel), and vegetable products like flaxseed oil and walnuts. Research shows that polyunsaturated fats are good for people. Studies have shown that it is good for heart health by playing a role in keeping blood cholesterol levels low, keeping irregular he
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Polyunsaturated fatty acid (Opti-EPA)
Study Locations (2)
Ohio
- MetroHealth Medical Center - Cleveland
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2006-04 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00323414
The ClinicalTrials.gov registry entry for NCT00323414 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 20 other Fatty Liver trials with a reported enrollment target (82% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fatty Liver appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00323414 reports 2 study locations spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00323414 about?
NCT00323414 is a clinical study titled "Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver". 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 developed countries. Among adults in the United States, the prevalence is between 5.7% and 17%. These ra...
What is the current status of trial NCT00323414?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2006-04. Estimated completion is 2011-12.
What conditions does trial NCT00323414 study?
This clinical trial studies the following conditions: Fatty Liver.
What interventions are being tested in trial NCT00323414?
The interventions under investigation include: Placebo (DRUG), Polyunsaturated fatty acid (Opti-EPA) (DRUG).
Who is sponsoring clinical trial NCT00323414?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00323414 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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