Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT02422238

Prospective Cohort, With Biobanking, of Patients With Nonalcoholic Fatty Liver Disease

Led by Maastricht University Medical Center · Updated on 2016-09-13

500

Participants Needed

1

Research Sites

652 weeks

Total Duration

On this page

Sponsors

M

Maastricht University Medical Center

Lead Sponsor

C

Centrum Obesitas-Eetstoornissen (CO-EUR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with proven NAFLD based on liver biopsy and/or MRI, is to study factors contributing to the development of NASH in patients with simple steatosis and to identify and validate non-invasive markers for the diagnosis of NASH.

CONDITIONS

Official Title

Prospective Cohort, With Biobanking, of Patients With Nonalcoholic Fatty Liver Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of NAFLD based on liver biopsy or MRI showing liver fat
  • Body mass index (BMI) of 30 kg/m2 or higher
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Unable to understand or sign informed consent
  • Causes of liver fat due to alcohol, medications, infections, or other diseases like Wilson's disease
  • Alcohol use over 14 drinks per week for men or over 7 drinks per week for women
  • Unable or unwilling to undergo MRI (e.g., due to claustrophobia or implanted devices)
  • Not willing to be informed about unexpected MRI results
  • Refusal to provide biological samples
  • Pregnancy or breastfeeding
  • Planned or recent bariatric surgery within one year
  • Diagnosis of liver cirrhosis or liver cancer
  • Current or recent (within 5 years) cancer outside the liver
  • Undergoing or recovering from medical procedures that interfere with study data collection, with possibility to join later

AI-Screening

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Trial Site Locations

Total: 1 location

1

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Actively Recruiting

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Research Team

K

Koek, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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