Plain English Summary
Background and study aims
Fatty liver disease is a term used to describe a range of conditions caused by a build-up of fat within the liver. A normal liver should have no, or very little, fat. Simple fatty liver, which is harmless, is common in people who are overweight or obese. Over time, however, simple fatty liver can develop into non-alcoholic steatohepatitis (NASH) where the liver becomes inflamed. At this stage, people might experience a dull ache in their abdomen but it often has no symptoms. Persistent inflammation of the liver can develop into fibrosis where fibrous scar tissue develops around liver cells and blood vessels. The liver is still able to function normally at this stage. The final stages are cirrhosis and end-stage liver disease, in which the scarring is so extensive that the liver shrinks, becomes lumpy and begins not to function normally. Recent information has shown that exercise may help people with fatty liver. It may help reduce the amount of fat in the liver by increasing the ability of the body to burn fat and increasing the sensitivity of the body to food. Evidence also suggests that exercise may help to reduce active injury and inflammation in the liver. We want to show the effect of exercise on the levels of fat, injury and inflammation in the liver and the sensitivity of the body to food.
Who can participate?
Adults aged at least 18 with diagnosed NASH, who not do a lot of exercise and are at a stable weight.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) undergo 12 weeks of supervised exercise. Those in group 2 (control group) do not attend any exercise sessions. Both groups of participants go to the research facility 5 times throughout the 12 week exercise period, in which the amount of fat in the liver is measured (using a magnetic resonance scanner) and blood tests are taken to check for liver injury and inflammation.
What are the possible benefits and risks of participating?
Being more physically active may be beneficial to the level of fat, injury and inflammation in the liver and if sustained after the study, may help in preventing other complications such as heart disease and diabetes. Participants in the intervention group have supervised exercise sessions (like a personal trainer) which will teach them about their body, show them how to exercise correctly and help them become more physically fit. Participants in the control group are given the opportunity to do a individualised exercise programme. There are minimal risks to taking part in the exercise programme.
Where is the study run from?
University of Newcastle upon Tyne (UK)
When is the study starting and how long is it expected to run for?
January 2013 to November 2014
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Julia Maddison
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13894
Study information
Scientific title
The effect of exercise on active liver injury, inflammation and liver lipid in people with non-alcoholic steatohepatitis
Acronym
Study hypothesis
To characterise the effects of resistance exercise upon factors which influence the development and progression of non−alcoholic steatohepatitis (NASH).
Ethics approval
Sunderland NRES committee, 02/01/2013, ref: 13/NE/0041
Study design
Randomised; Interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Metabolic and endocrine disorders, Hepatology; Subtopic: Metabolic and Endocrine (all Subtopics), Hepatology; Disease: Metabolic & Endocrine (not diabetes), All Hepatology
Intervention
Participants will undergo five metabolic assessment visits to the research facility, interspersed by either 12 weeks of supervised exercise therapy or continue their normal care.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Liver lipids, abdominal fat content, insulin sensitivity; Timepoint(s): 12 weeks
Secondary outcome measures
N/A
Overall trial start date
01/03/2013
Overall trial end date
10/11/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. NASH confirmed by liver biopsy; this is the study group
2. Sedentary; we are looking at the effect of increased exercise
3. The person's weight needs to be stable as we are interested in the independent effect of exercise
4. Aged 18 years and over
5. Understanding of English (as without this supervised gym visits will not be possible)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 28; UK Sample Size: 28; Description: 14 participants per group to allow 3 people from each group to leave the study and retain sufficient power.
Participant exclusion criteria
1. NASH confirmed by liver biopsy; this is the study group
2. Sedentary; we are looking at the effect of increased exercise
3. The person's weight needs to be stable as we are interested in the independent effect of exercise
4. Aged 18 years and over
5. Understanding of English (as without this supervised gym visits will not be possible)
Recruitment start date
01/03/2013
Recruitment end date
01/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Newcastle upon Tyne
Mitochondrial Research Group
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Will be presented at liver conferences such as the European Association for the Study of Livers
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27521509