Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT04198805
Eligibility Criteria:
Inclusion Criteria:
* Male or female gender
* ≥18 years of age
* A new diagnosis or reconfirmation of previously known fatty liver by imaging (ultrasound or CT or MRI), or by liver biopsy within ≤ 4 years
* Fibroscan CAP score \>300db
* Hepatic fat fraction ≥12% by MRI PDFF
* ALT≥ 40 U/L
* eGFR/Creatinine Clearance ≥ 60ml/min
* Participants with previously diagnosed Type 2 diabetes (up to 50% of sample): they must either be taking anti-diabetic medications, or their fasting (\>10 hours) glucose must be ≥ 100 mg/dL at the time of screening
* Stable weight (±5%) for at least 3 months
* Subjects willing and able to give written informed consent and to understand, to participant and to comply with the clinical study requirements.
Exclusion Criteria:
* Evidence of alternative causes of hepatic steatosis or other forms of chronic liver disease, e.g. Hep.B, Hep.C
* Evidence of acute Hepatitis A
* Serum ALT or AST ≥ 250 U/L
* Serum Alkaline Phosphatase \> 2 ULN
* Total bilirubin \> 2 ULN in the absence of Gilbert's Syndrome \[In patients with Gilbert's Syndrome, direct bilirubin must not exceed 2 ULN\]
* HbA1c≥9.5%
* Decompensated acute or chronic liver disease
* Clinical, imaging or histological evidence of cirrhosis
* Use of anti-NASH drugs (e.g. thiazolidinediones) in the 3 months prior to randomization
* Use of a non-stable dose of statins or fibrates in the 3 months prior to randomization
* Use of fish oil, algal oil or Krill oil supplements, drugs or foods fortified with omega-3s in the 2 months prior to randomization (\>200mg DHA/d and/or \>60mg EPA/d by FFQ)
* Known intolerance to vitamin E or DHA
* Malabsorption of Vit E (e.g. due to steatorrhea, chronic pancreatitis, severe cholestasis)
* Vitamin E supplementation of greater than 100 IU/day in the 3 months prior to randomization
* History of bariatric surgery (jejunoileal bypass or gastric weight loss surgery) or currently undergoing evaluation for bariatric surgery
* History of biliary diversion
* Known positivity for antibody to Human Immunodeficiency Virus (HIV)
* Patients with coagulopathy (PT ≥3 sec.from ULN), thrombocytopenia (\<70K)
* Contraindication to MRI (implants, metal…)
* Active, serious medical disease or disease diagnosis of a life-expectancy less than 5 years
* Ongoing or recent alcohol consumption \> 21 drinks (1 drink= 12 oz regular beer, or 5 oz wine, or 1.5 oz distilled spirits) per week in men and \> 14 drinks per week in women as per subject self-report as part of medical history.
* Active substance abuse, such as oral, inhaled or injected illicit drugs (except marijuana), in the year prior to screening
* Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial
* Women who are breastfeeding
* Any other condition which, in the opinion of the investigator would impede compliance or hinder completion of the study
* Subjects who are enrolled in an interventional clinical study or have received an investigational new drug or product within the last 30 days prior to screening
* Participants diagnosed with type 1 diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04198805
Study Brief:
Protocol Section:
NCT04198805