Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 75 years old (male or female)
• People who are able to understand and sign a written consent form
• People who are already scheduled to have a standard liver biopsy using a needle into the right side of the liver, either through the skin or through a neck vein
• People suspected of having a liver condition called NAFLD (a type of fat-related liver disease) who are being considered for treatment, and who also have two or more of the following risk factors:
  • Elevated liver enzymes (ALT of 40 or above)
  • A body mass index (BMI) of 25 or above
  • High blood pressure
  • Type 2 diabetes
  • Abnormal blood fat levels (dyslipidaemia)
  • Low "good" cholesterol (HDL below 40 mg/dl in men or below 50 mg/dl in women)
  • High triglycerides (150 mg/dl or above)
  • High total cholesterol (200 mg/dl or above)
  • A triglyceride-to-HDL ratio above 5.0

Who may not be able to join:

• People who have already been diagnosed with NASH (a more advanced stage of fatty liver disease) through a previous biopsy
• People who are unable to have a liver biopsy
• People who have had, or are planning to have, a liver transplant
• People scheduled for a different type of liver biopsy (such as a laparoscopic, wedge, or left-lobe biopsy)
• People who have taken part in another investigational drug trial within the 30 days before enrolling
• People with another known cause of chronic liver disease, such as alcohol-related liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, haemochromatosis or iron overload, a condition called A1AT deficiency, or hepatitis B or C
• People with a history of cirrhosis or serious liver complications such as fluid build-up in the abdomen, confusion caused by liver failure, or bleeding from enlarged veins
• People with significant drug or alcohol misuse in the 12 months before screening
• People who are unable to have an MRI scan for any reason, including:
  • Severe claustrophobia (the MRI scan takes 15–30 minutes)
  • Having a pacemaker or other implanted electronic device
  • Having certain metal objects in the body (such as an aneurysm clip) that could interfere with the scan or be affected by the magnetic field
  • Being unable to lie flat, stay still, or briefly hold their breath during the scan
• People with a medical condition likely to cause significant fluid retention, such as congestive heart failure
• People whose body size makes positioning in the MRI scanner difficult
• People who have had weight-loss surgery within the past 3 years
• People with certain other serious medical conditions, as determined by the investigating doctor (examples include HIV, recent major surgery, uncontrolled heart disease, active infection, illicit drug use, or cancer)
• People with a significant medical or psychiatric condition that the investigator considers too high-risk for participation
• People who do not give informed consent

Important: Always verify eligibility with the trial site directly before applying.