diet and lifestyle program for Liver Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Liver Diseases+3 More
diet and lifestyle program - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a very low carbohydrate diet can improve liver health in people with non-alcoholic fatty liver disease.

See full description

Eligible Conditions

  • Liver Diseases
  • Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether diet and lifestyle program will improve 1 primary outcome and 2 secondary outcomes in patients with Liver Diseases. Measurement will happen over the course of 4 months.

4 months
Change in MRI-based liver fibrosis
Change in liver fat content using liver MRI-derived proton density fat fraction
Percent body weight change

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

diet and lifestyle program
1 of 1
Experimental Treatment

This trial requires 40 total participants across 1 different treatment group

This trial involves a single treatment. Diet And Lifestyle Program is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

diet and lifestyle program
Behavioral
Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindful eating.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
diet and lifestyle program
2017
Completed Phase 2
~150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 months for reporting.

Who is running the study

Principal Investigator
L. S.
Prof. Laura Saslow, Assistant Professor
University of Michigan

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
have elevated liver function tests
have regular access to the internet
MRI with liver steatosis but nor cirrhosis
Able to consent and follow directions
No physical limitations
Physician approval to participate
Able to attend in-person appointments in Ann Arbor Be identified based on information from the Michigan Genomics Initiative (MGI) database

Patient Q&A Section

What are common treatments for nonalcoholic steatohepatitis?

"The most common treatment for NASH is caloric restriction or weight reduction. Liver biopsy and/or treatment for nonalcoholic steatohepatitis are not usually recommended without definite clinical evidence of steatohepatitis." - Anonymous Online Contributor

Unverified Answer

How many people get nonalcoholic steatohepatitis a year in the United States?

"Between 712,900 and 798,300 individuals in the US are diagnosed with NAFLD or NASH annually, yielding a prevalence for NASH of 2.1-2.5% of adults. The age at diagnosis has decreased over time and has shifted from a female biased to male biased pattern." - Anonymous Online Contributor

Unverified Answer

What causes nonalcoholic steatohepatitis?

"In the great majority of subjects, the cause of NASH was not determined. Among men with a known cause of alcoholism the risk of a NASH diagnosis was found to be lower. NASH is not a homogenous disease, and its cause is likely multifactorial with genetic and environmental factors and complex interactions between them." - Anonymous Online Contributor

Unverified Answer

Can nonalcoholic steatohepatitis be cured?

"Although [there have been] many reported case series and uncontrolled clinical studies, the treatment of NASH is still in its early stages and there is no established treatment standard. Nevertheless, a number of treatments can lead to histologic clearance with or without symptomatic resolution of hepatologic dysfunction for patients with fibrosis stage 1 or 2; however, some patients with advanced fibrosis stage will experience only minimal or no symptomatic resolution of morbidity; their prognoses [are] strongly related to their underlying medical comorbidities." - Anonymous Online Contributor

Unverified Answer

What is nonalcoholic steatohepatitis?

"Nonalcoholic steatohepatitis is a collection of signs and symptoms in a person with fatty liver and steatosis. It presents with abnormal blood tests, elevated liver cancer markers, and abdominal imaging studies. A genetic component has been demonstrated to cause the development of nonalcoholic steatohepatitis, particularly in women with a family history of the condition. Obesity also predisposes to development of nonalcoholic steatohepatitis. Nonalcoholic steatohepatitis affects approximately 20 million Americans and is responsible for 1% of all deaths in the United States." - Anonymous Online Contributor

Unverified Answer

What are the signs of nonalcoholic steatohepatitis?

"NASH may rarely present with a picture of acute hepatotoxicity, and hepatotoxicity is an important cause of the death of patients with NASH. The presence of hepatic encephalopathy may be a strong indicator of NASH. Also, the presence of hepatitis is common in cases of NASH, and hepatic encephalopathy may be manifested as a manifestation of this hepatitis." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets nonalcoholic steatohepatitis?

"The average age of NASH diagnosis is 55 in men and 49 in women in the United States. In the United Kingdom, NASH typically occurs earlier at the age of 42 in men and 30 in women." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating nonalcoholic steatohepatitis?

"It is unknown (https://www.ncbi.nlm.nih.gov/entrez/genomeview.fcgi?DB=HGNC) how to treat nonalcoholic steatohepatitis. But there is a lot of information that is gathered from the research that has been done to create treatments and new biomarkers for nonalcoholic steatohepatitis.(DOI: 10.1002/ajpj.4277) If you are interested in treating nonalcoholic steatohepatitis, you can use [Power(http://www.withpower.com/clinical-trials) to search trials tailored to your condition." - Anonymous Online Contributor

Unverified Answer

Has diet and lifestyle program proven to be more effective than a placebo?

"Diet and lifestyle program proved to be more effective than placebo in modifying nonalcoholic steatohepatitis features and improving liver function, but not in reducing liver inflammation." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of nonalcoholic steatohepatitis?

"In more than 45% of patients with non-AFLD fatty liver, NASH is primary. The main factors associated with NASH were insulin resistance and obesity. In patients with non-AFLD NASH, the severity of steatosis is associated with the BMI and insulin resistance." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for nonalcoholic steatohepatitis?

"There were no significant differences in short-term outcomes in response to placebo and UDCA at 12 weeks of treatment in this small group of patients with nonalcoholic steatohepatitis. Prospective trials are needed to determine the optimal treatment approach in this subset of patients with nonalcoholic steatohepatitis." - Anonymous Online Contributor

Unverified Answer

Is diet and lifestyle program safe for people?

"Results of diet and lifestyle programs are similar in general to those of pharmacological treatments, with low rates of adverse effects. People choose treatments based on clinical appropriateness, safety, cost, convenience, and the individual's preference, and with the support of doctors who specialize in treating disease or condition, and not on the efficacy of a program. In a recent study, findings demonstrate that if the objectives of a programme are achievable with the available resources and in a safe manner, then it can provide sustained benefit to a range of people. If possible, it is also advisable to carry out a pilot trial to determine if such objectives are achievable and if they are." - Anonymous Online Contributor

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