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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 NAFLD - Non-Alcoholic Fatty Liver Disease, sponsored by Jeffrey Browning.

Completed
Registry status
NA
Development phase
70
Enrollment target
1
Study location

NCT02690792 is a NA study of Healthy and NAFLD - Non-Alcoholic Fatty Liver Disease 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.

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The verdict

NCT02690792, a NA study of Healthy and NAFLD - Non-Alcoholic Fatty Liver Disease, 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.

Interventions

  • OTHER NAFLD/NASH - Placebo
  • DIETARY_SUPPLEMENT NAFLD/NASH - Vitamin E

Study Locations (1)

Texas

  • University of Texas Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2009-12
Est. Completion 2016-12
Phase NA

Sponsor

Jeffrey Browning

1 total trials

What the Registry Record Tells You About NCT02690792

The ClinicalTrials.gov registry entry for NCT02690792 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The listed sponsor is Jeffrey Browning, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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, NAFLD - Non-Alcoholic Fatty Liver Disease, NASH (Non-Alcoholic Steatohepatitis).

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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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