Effect of Vitamin E on Non-Alcoholic Fatty Liver Disease
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|ClinicalTrials.gov Identifier: NCT02690792|
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : November 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy NAFLD (Non-Alcoholic Fatty Liver Disease) NASH (Non-Alcoholic Steatohepatitis)||Other: NAFLD/NASH - Placebo Dietary Supplement: NAFLD/NASH - Vitamin E||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Role of Mitochondrial Dysfunction in Non-Alcoholic Fatty Liver Disease|
|Actual Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Placebo Comparator: NAFLD/NASH - Placebo
In NAFLD/NASH Group: Identically appearing Placebo capsules given as double-blinded, randomized intervention as a comparator to Vitamin E intervention.
Dosage: Placebo capsules. Two capsules by mouth each morning and two capsules by mouth each evening for 4 months.
Other: NAFLD/NASH - Placebo
Placebo capsules, 2 capsules by mouth each morning and 2 capsules by mouth each evening for 4 months.
Active Comparator: NAFLD/NASH - Vitamin E
In NAFLD/NASH Group: Vitamin E capsules given as double-blinded, randomized intervention as a comparator to Placebo capsules intervention.
Dosage: Vitamin E 200 IU/capsule. Two capsules by mouth each morning and two capsules by mouth each evening for 4 months.
Dietary Supplement: NAFLD/NASH - Vitamin E
Vitamin E 200 IU capsule, 2 capsules by mouth each morning and 2 capsules by mouth each evening for 4 months.
- Change in Measurement of percentage of Liver Fat by MRI [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks ]Measurement of percentage of Liver Fat by MRI at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks.
- Change in Measurement of Insulin Sensitivity via Hyperinsulinemic glucose clamp [ Time Frame: 4 months ]Measurement of insulin sensitivity by glucose disposal rate (mg/Kg/min) via hyperinsulinemic glucose clamp @ baseline and 16 weeks.
- Change in Measurement of glucose metabolism turnover by non-radioactive isotopic infusion and recovery [ Time Frame: 4 months ]Measurement of glucose metabolism turnover (ug/Kg/min) in the liver by non-radioactive isotopic infusion and recovery @ baseline and 16 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690792
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390-8568|
|Principal Investigator:||Jeffrey D Browning, M.D.||University of Texas Southwestern Medical Center|