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

NCT02422238 | Recruiting

• 1 other identifier: METC142074
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Development of NASH

  10 years

Secondary Outcomes (2)

• Prevalence of hepatic complications of NAFLD

  10 years

• Prevalence of extrahepatic complications of NAFLD

  10 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obese ( BMI ≥ 30 kg/m2) subjects with proven NAFLD either by imaging (using MRI) or histology, referred to secondary or tertiary care for obesity related problems will be asked to participate in this study.

You may qualify if:

• NAFLD diagnosis based on evidence of hepatic steatosis, either by imaging (using MRI) or by histology.
• BMI ≥ 30 kg/m2
• Between 18 - 65 years of age

You may not qualify if:

• Incompetent to understand and/or sign the informed consent.
• Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis
• Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female.
• Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker).
• Not willing to be informed about unexpected findings by MRI
• Unwilling to collect bio samples.
• Pregnancy and breastfeeding.
• Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
• Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.
• Individuals about to undergo or recovering from a surgical or otherwise medical procedure that will interfere with data collection and analyses planned within the current cohort, will initially be excluded from participation, but are offered the opportunity to participate at a later moment in time

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Centrum Obesitas-Eetstoornissen (CO-EUR): collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

RECRUITING

Related Publications (1)

• Shami GJ, Samarska IV, Koek GH, Li A, Palma E, Chokshi S, Wisse E, Braet F. Giant mitochondria in human liver disease. Liver Int. 2023 Nov;43(11):2365-2378. doi: 10.1111/liv.15711. Epub 2023 Aug 24.

  PMID: 37615254 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, faeces and exhaled air will be collected. The buffy coat of blood collected in an EDTA-tube to obtain plasma, will be stored for isolation of DNA.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Koek, MD, PhD

CONTACT

0031-43-3875021

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 21, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

NL (1)