MRI and Stable Isotope Tracer Studies for Detecting the Progression of Non-Alcoholic Steatohepati… (NCT04227782) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MRI and Stable Isotope Tracer Studies for Detecting the Progression of Non-Alcoholic Steatohepatitis (NASH)
United Kingdom40 participantsStarted 2020-03-01
Plain-language summary
One-third of the world's population suffers from Non-Alcoholic Fatty Liver Disease (NAFLD), that is a disease with an accumulation of fat in the liver. Some patients with NAFLD will progress in their disease to develop inflammation, scarring of the liver tissue, and cirrhosis that can lead to liver failure. The mechanisms of the disease and its progression are still not fully understood. It is therefore critical to find early markers that can identify the patients that will progress so that they can be treated early.
A compound called L-carnitine, synthesised in the body from two amino acids; lysine and methionine, is critical for fat metabolism. Some studies have shown that it is decreased in liver disease patients and that L-carnitine supplementation can protect the liver function.
This study aims to increase the understanding of the mechanisms behind NAFLD disease progression through its different stages. This may help diagnostic methods to be developed to predict the patients at risk for developing severe liver disease. Furthermore, fat metabolism and L-carnitine levels will be established in the different disease stages to evaluate whether fat metabolism could be compromised.
Magnetic Resonance Imaging (MRI) will be used for imaging of the whole liver and the heart to investigate metabolism and function non-invasively. Whole-body metabolism and how carbohydrates are taken up from diets are converted to fats in the body will be explored using stable isotope labelling. This study will recruit 30 participants with NAFLD; 10 each for low-risk NALFD, biopsy-proven NASH and compensated NASH cirrhosis. Participants will undergo MRI, followed by a stable isotope labelled study, where through blood- and breathe samples, metabolism will be investigated.
An additional 10 healthy participants will be assessed using MR techniques to assess whether an injection of L-carnitine can lead to increase of L-carnitine in the liver such that it can be detected by MR. This is to validate a methodology prior to using it in NAFLD participants.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged ≥18
* In cases where histologic evidence is needed, the pathologist evaluation of a liver biopsy should be obtained within 90 days prior to screening.
Participants with simple steatosis
* Liver biopsy that shows features of simple steatosis and no signs of advanced fibrosis or NASH (F3) or cirrhosis (F4). Simple steatosis will be defined as the presence of lipid inclusions in ≥ 5% of hepatocytes without both of lobular inflammation and hepatocyte ballooning. Steatosis with either lobular inflammation or ballooning will be included in this category provided there is no bridging fibrosis (\<F3 on the NASH CRN fibrosis classification system), OR
* Findings of fatty liver on ultrasound in patients with low risk of NASH or advanced fibrosis defined as liver stiffness measurement \<8kPa.
Participants with NASH:
o Liver biopsy that shows presence of all the features of NASH (≥ 5% steatosis, lobular inflammation and hepatocyte ballooning) and without liver cirrhosis. Low-grade fibrosis are allowed.
Participants with NASH cirrhosis:
* Liver biopsy that shows features of NASH cirrhosis. Historical liver biopsies will be acceptable provided there has been no significant weight loss (\> 5% of body weight) between the time of biopsy and recruitment, OR
* Presence of metabolic comorbidities and clinical (stigmata of chronic liver disease), radiological (e.g. irregular liver edge, features of portal hypertension), laboratory (deranged clotting, low platelet…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in whole-body fatty acid oxidation in a stable isotope labelled postprandial study day in participant groups.