Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT03308916 Sponsor: Maja Thiele Condition: Non-Alcoholic Fatty Liver Disease
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Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT03308916
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 30 to 75 years (or 40 to 75 years for those joining as part of the general population group)
  • People who are able to give their consent to take part in the study
  • People who are able to read and write in Danish
  • People who have had, or currently have, a high level of alcohol use — meaning an average of at least 14 standard drinks per week for women, or 21 standard drinks per week for men, over at least 5 years; OR
  • People who have metabolic syndrome, meaning excess weight around the waist plus at least two of the following: high triglycerides (a type of fat in the blood), low "good" (HDL) cholesterol, high blood pressure, or high fasting blood sugar; OR
  • People who have been diagnosed with type 2 diabetes, confirmed through one or more blood sugar tests meeting specific levels (confirm with trial site for exact values)

Who may not be able to join:

  • People who have signs of serious liver failure, such as fluid build-up in the abdomen, confusion caused by liver problems, yellowing of the skin or eyes, or large swollen veins in the food pipe with or without bleeding
  • People who have a known liver condition other than alcohol-related liver disease or fatty liver disease (NAFLD)
  • People who have cancer or another serious illness where life expectancy is less than 12 months
  • People who would not be able to follow the study plan as required
  • People for whom a liver tissue sample (biopsy) cannot safely be taken, if that step becomes relevant
  • People who have severe liver inflammation shown by blood test results more than three times above the normal range, if a liver biopsy step is reached
  • People who show signs of fluid congestion around the liver or blocked bile ducts on ultrasound, if a liver biopsy step is reached
  • People whose liver stiffness measurement drops below a certain level between their initial assessment and the planned biopsy date (confirm with trial site)

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Maja Thiele, MD, PhD, Professor, Department of Gastroenterology and Hepatology, Odense University Hospital

Phone: +4524998068

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Maja Thiele
Registry
ClinicalTrials.gov
Start date
6 October 2017
Est. completion
30 December 2025

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Biopsy-verified advanced fibrosis; Liver-related outcomes

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov