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NCT02690792 · ClinicalTrials.gov registry record · NA
Effect of Vitamin E on Non-Alcoholic Fatty Liver Disease
A NA study of Healthy and NASH - Nonalcoholic Steatohepatitis, sponsored by Jeffrey Browning.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT02690792: Completed NA study of Healthy and NASH - Nonalcoholic Steatohepatitis, sponsored by Jeffrey Browning.
NCT02690792 is a NA study of Healthy and NASH - Nonalcoholic Steatohepatitis that has completed, run by Jeffrey Browning. The registered enrollment target is 70 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02690792, a NA study of Healthy and NASH - Nonalcoholic Steatohepatitis, has completed, sponsored by Jeffrey Browning.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
One-third of the US population has non-alcoholic fatty liver disease (NAFLD) due to obesity and \~8 million of these individuals have a progressive form of the disease, non-alcoholic steatohepatitis (NASH). Currently, there are no noninvasive ways to determine which individuals with NAFLD will develop NASH. This is of medical importance since NASH can be a prelude to the development of end-stage liver disease. The study of NAFLD has been limited by several factors, including the difficulties associated with studying liver metabolism in vivo in humans. Our group has pioneered new methods that use nuclear magnetic resonance (NMR) to measure intermediary hepatic metabolism in humans with a goal of directly studying the pathophysiology of bland steatosis and NASH. In this study, these noninvasive methods will be used to characterize and compare the metabolic alterations that accompany bland steatosis and NASH and test the hypothesis that detects if hepatic mitochondrial metabolism contribute to both disorders. Such characterization is fundamental to establishing a rational approach to the prevention and treatment of NAFLD and may provide simple, non-invasive methods to differentiate benign and progressive forms of NAFLD. This proposal will be addressed via separate isotopic studies occurring at different time points during a prolonged fast. In subjects with NAFLD, these studies will be carried out before and after treatment with Vitamin E or placebo. Healthy subjects will participate in initial baseline studies only without Vitamin E or placebo intervention. The study is designed to harness the physiologic changes that occur with short- and long-term fasting to provide a rapid and cost-effective method to accomplish the aims of the application.
Primary Outcome
Measurement of percentage of Liver Fat by MRI at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks.
Conditions Studied
Interventions
- OTHER NAFLD/NASH - Placebo
- DIETARY_SUPPLEMENT NAFLD/NASH - Vitamin E
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2009-12 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT02690792 record still lists
NCT02690792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which NAFLD/NASH - Placebo is the first listed.
NCT02690792 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02690792 about?
NCT02690792 is a clinical study titled "Effect of Vitamin E on Non-Alcoholic Fatty Liver Disease". One-third of the US population has non-alcoholic fatty liver disease (NAFLD) due to obesity and \~8 million of these individuals have a progressive form of the disease, non-alcoholic steatohepatitis (NASH). Currently, there are no noninvasive ways to determine which individuals with NAFLD will devel...
What is the current status of trial NCT02690792?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2009-12. Estimated completion is 2016-12.
What conditions does trial NCT02690792 study?
This clinical trial studies the following conditions: Healthy, NASH - Nonalcoholic Steatohepatitis, NAFLD - Non-Alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT02690792?
The interventions under investigation include: NAFLD/NASH - Placebo (OTHER), NAFLD/NASH - Vitamin E (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02690792?
This trial is sponsored by Jeffrey Browning, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02690792 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02690792's enrollment target sits among peer trials
70 325th of 1090 higher than 759 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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