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NAFLD-cohort: Prospective Cohort, With Biobanking, of Patients With Nonalcoholic Fatty Liver Disease

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02422238
Collaborator
Centrum Obesitas-Eetstoornissen (CO-EUR) (Other)
500
Enrollment
1
Location
150
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Non-alcoholic fatty liver disease (NAFLD) is with 20-30% the most prevalent liver disorder in Western society. Most patients with NAFLD have no or few, mainly aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality.

    Further insight in factors contributing to the initiation of NASH in patients with simple steatosis and early diagnosis are essential for identifying future therapeutic options and to limit the risk of complicated NASH (i.e. fibrosis, and cirrhosis with portal hypertension) HCC, liver-related mortality and extrahepatic morbidity.

    This cohort study, with both a cross-sectional and a longitudinal part, will include obese subjects (BMI ≥ 30 kg/m2, age 18-65) with proven NAFLD based on liver biopsy and/or MRI.

    All participants will be asked to complete several questionnaires (i.e. demographics, clinical data, SF-36, GAD-7 and PHQ-9, FFQ, SQUASH, and Baecke), and to undergo anthropometric measurements. Furthermore, blood, urine, faeces and exhaled air will be collected and a fibroscan and DEXA-scan will be performed. Additionally, participants will be asked to participate in a multi-sugar test for intestinal permeability.

    The majority of eligible subjects will undergo/have undergone a MRI or liver biopsy for clinical reasons. It is to be expected that about 33% of subjects will be asked to undergo a MRI for study purpose only.

    After 5 and 10 years, participants will be invited to undergo in the same study procedures, data and sample collection to study the factors responsible for the development of NASH in the group with simple steatosis at baseline, and the development of (extra)hepatic complications in the group with NASH at baseline.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Disease Mechanisms and Markers for Non-alcoholic Steatohepatitis in a Population With Non-alcoholic Fatty Liver Disease: a Prospective Cohort Study With Biobank
    Study Start Date :
    Jun 1, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2017
    Anticipated Study Completion Date :
    Dec 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Development of NASH [10 years]

    Secondary Outcome Measures

    1. Prevalence of hepatic complications of NAFLD [10 years]

    2. Prevalence of extrahepatic complications of NAFLD [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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.

    • Indication or planned for bariatric surgery within one year after inclusion or a history of bariatric surgery.

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Medical Center Maastricht Limburg Netherlands

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ger Koek, MD, PhD, Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02422238
    Other Study ID Numbers:
    • METC142074
    First Posted:
    Apr 21, 2015
    Last Update Posted:
    Sep 13, 2016
    Last Verified:
    Sep 1, 2016
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Sep 13, 2016