Phase 4 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:

• You have been diagnosed with type 2 diabetes within the last 5 years
• You are willing to take part, understand what the trial involves, and are happy to sign a consent form and follow all study requirements
• Your blood sugar is managed either through diet and exercise alone, or you have been on one or two diabetes medications (from a specific approved list) at a stable dose for at least 8 weeks
• Your HbA1c (a measure of average blood sugar over roughly 3 months) is between 7.0% and 8.5%
• You have also been diagnosed with non-alcoholic fatty liver disease (a condition where fat builds up in the liver, not caused by alcohol)

Who may not be able to join:

• You have type 1 diabetes, diabetes related to pregnancy, or another specific type of diabetes
• You have had a serious diabetes complication in the past 6 months, such as dangerously high blood sugar requiring emergency care
• You have had serious eye, nerve, circulation, or foot problems related to diabetes in the past 6 months
• You have serious liver disease, advanced kidney disease, or other significant conditions such as pancreatitis or liver cirrhosis
• You had a heart attack, unstable chest pain, stroke, or a major heart procedure in the past 6 months, or you have advanced heart failure or a life-threatening irregular heartbeat
• You have had a bleeding or blockage stroke in the past 6 months that researchers feel makes participation unsuitable
• You have high blood pressure that is not well controlled (readings at or above 160/100 mmHg)
• You have a hormonal condition (other than diabetes) that affects your weight, blood sugar, or fats in the blood, such as an overactive thyroid or Cushing's syndrome
• You have been diagnosed with a cancer (other than a treated skin basal cell carcinoma) in the past 5 years
• You have had a serious infection, major injury, or major surgery in the past 3 months
• You have a history of substance or drug misuse in the past 5 years
• You have taken part in another clinical drug or device trial in the past 3 months
• You have severe anaemia or need regular blood transfusions
• You have taken medications that affect your weight (such as water tablets or weight-loss drugs) in the past 90 days
• You have taken medications that significantly affect blood sugar for more than 1 week in the past 12 weeks (such as steroid tablets, growth hormone, or certain antipsychotic medications) — note that low-dose blood pressure water tablets may be allowed (confirm with trial site)
• You have had weight-loss (bariatric) surgery or are planning to have it
• Your liver enzyme levels (ALT/AST) are more than 5 times higher than the normal upper limit
• Your kidney filtering function is significantly reduced (eGFR below 40, measured by a specific formula)
• You are currently pregnant, breastfeeding, or planning to become pregnant
• You have a history of hepatitis B, hepatitis C, tuberculosis, HIV, or syphilis
• You have taken certain liver-related treatments (such as vitamin E, ursodeoxycholic acid, or similar drugs) within the past 3 months
• You have a structural or functional problem with your urinary or reproductive system that makes infections more likely
• You have a blood or red blood cell disorder
• You have taken immune-suppressing medications such as cyclosporine or cyclophosphamide
• You have metal implants or devices in your body that are not compatible with MRI scanning

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