Treatment for Fatty Liver

1
Effectiveness
2
Safety
Cleveland Clinic Foundation, Cleveland, OH
Fatty Liver+4 More
Eligibility
18+
All Sexes
Eligible conditions
Fatty Liver

Study Summary

This study is evaluating whether vitamin E may help treat nonalcoholic fatty liver disease.

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Eligible Conditions

  • Fatty Liver
  • Nonalcoholic Steatohepatitis
  • Liver Diseases
  • Non Alcoholic Steatohepatitis (NASH)
  • Non-alcoholic Fatty Liver Disease
  • Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Fatty Liver. Measurement will happen over the course of 24 weeks.

24 weeks
Mean change in hepatic steatosis (fat in the liver) score determined by Fibroscan® Controlled Attenuation Parameter (CAP) software function
Mean change in liver stiffness from baseline assessed by Fibroscan®
Mean change in serum alanine aminotransferase (ALT) from baseline
Mean change in serum aspartate aminotransferase (AST) from baseline
Proportion of patients achieving normalization of alanine aminotransferase (ALT) at 24 weeks
Relative change in alanine aminotransferase (ALT) from baseline to 24 weeks

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

4 Treatment Groups

Vitamin E, 200 IU
Placebo group

This trial requires 200 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Vitamin E, 200 IU
Drug
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Placebo
Drug
matching placebo taken once daily with breakfast
Vitamin E, 400 IU
Drug
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E, 800 IU
Drug
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 weeks for reporting.

Closest Location

Cleveland Clinic Foundation - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 years of age or older as of the initial screening interview and provision of consent
FibroScan CAP>280 dB/m within 60 days prior to randomization.
ALT ≥ 60 U/L within 30 days of randomization

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes fatty liver?

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A combination of genetic and environmental factors are likely to play a part in the development of NAFLD, as are the effects of obesity and metabolic alterations.

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What are the signs of fatty liver?

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Fatty liver is a common cause of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It can be suspected by a raised levels of liver enzymes, abnormal liver scans and [alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\n\n-A1 (https://alzheimerassociation.org/what-do-your-family-and-friends-believe-is-the-most-important-stage-2-dementia)<br>\n-A2 (https://alzheimerassociation.

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What are common treatments for fatty liver?

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It is important to determine the cause of an elevation in serum transaminases. The differential diagnosis for causes of transaminase elevation include fatty liver, hepatitis, hepatic adenoma, liver metastasis, and other liver diseases. Treatment is dependent on exact cause. If fatty liver is the cause, cessation of alcohol consumption is a reasonable first step. If liver metastases are the cause, specific systemic therapies like chemotherapy should be considered first. If liver adenoma is the cause, alpha blockers may be used to decrease the production of estrogen, and estrogen-replacement therapies may be prescribed in the case of a uterus body tumor.

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What is fatty liver?

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Based on the definition of fatty liver by the NICE, the presence of liver abnormalities including fibrosis, atrophy with steatosis or nonalcoholic fatty liver disease is not enough to diagnose fatty liver. Further work-up should be carried out if there is a suspicion of fatty liver if they feel in doubt, to reduce the number of patients who have hepatic biopsies with a potentially negative finding, and help direct them to liver disease clinic services.

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How many people get fatty liver a year in the United States?

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In the United States, fatty liver affects 3 percent of people 40 yr old or older and 5 percent of those 50 yr old or older. The American Heart Association Guidelines suggest screening adults for fatty liver if they are 20 yr old or older. A review of the literature indicates that hepatitis B is also a major risk factor for fatty liver disease and it is recommended that vaccination for hepatitis B be included in the practice of primary care.

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Can fatty liver be cured?

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A significant improvement may be achieved in fatty liver patients by maintaining a healthy and active lifestyle, a high-fiber diet and exercise, and discontinuing alcohol.

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Does fatty liver run in families?

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The prevalence of FL in parents and their children was 34.5% and 22.5%, respectively. Familial transmission accounted for most of the cases. The prevalence was similar in men and women, but the frequency of FL was higher in men than in women. Age of onset of FL increased with the number of family members at risk with no apparent trend among parents. The occurrence of FL was higher for carriers of HFE (C282Y) mutation than HFE (H63D or Q282X) mutation for the first family member who developed FL. FL was not associated with the prevalence of HFE mutations in probands or siblings.

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Is treatment typically used in combination with any other treatments?

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Currently, no well-controlled studies of the effects of various treatment combinations on patients with non-severe fatty liver are available in the literature. To our knowledge, we report the first experience concerning the use of other treatments in combination with NAFLD-related treatments in patients with non-severe fatty liver.

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Does treatment improve quality of life for those with fatty liver?

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The present study demonstrates that a single course of medical therapy and exercise has a favorable impact on Quality of Life in both genders and that these effects are sustained post treatment for up to six months.

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Have there been any new discoveries for treating fatty liver?

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There were very few advances in fatty liver research between the beginning of the 20th century and the year 2000. The main advances of last 60 years were, 1) the discovery in 1974 of Metabolic Syndrome, 2) a better understanding in the 1980s of Fibrosis as the main culprit of the liver damage and NASH, and 3) New approaches using a combination of physical training and caloric restriction for weight loss.

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Who should consider clinical trials for fatty liver?

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Patients with NAFLD and/or NASH were less likely to respond to lifestyle changes alone despite similar levels of obesity, insulin resistance, and hepatic enzyme abnormalities. Patients with NAFLD are more likely to be candidates for lifestyle therapy. Patients with NAFLD have been demonstrated to have histopathologic features of fibrosis. However, only those with NAFLD and associated fibrosis were more likely to benefit from intervention.

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Have there been other clinical trials involving treatment?

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There are many clinical trials for the treatment of chronic liver disease including alcoholic hepatitis. The following are the trials for fatty liver disease.\n\nFatty liver disease results from excess accumulation of fat in the liver and is one of the criteria for Non-alcoholic Fatty Liver Disease (NAFLD). NAFLD is one of the major manifestations of non-alcoholic steatohepatitis (NASH) which is the second most common cause of fibrosis and cirrhosis in America. NAFLD also plays a crucial role in the development of type 2 diabetes and metabolic syndrome.

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