Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
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⁃ Patients are eligible for screening if the following inclusion criteria are fulfilled:

• Age 30-75 years (except the general population, which should be aged 40-75)

• Informed consent to study investigations

• Ability to read and write Danish AND (only at-risk patients)

• Prior or current alcohol overuse, defined as an average intake of ≥24 grams/day (14 units/week) for women and ≥36 grams/day (21 units/week) for men, for at least 5 years; OR

• Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;\[38\] OR

• Type 2 diabetes mellitus defined by either fasting plasma glucose ≥7 mmol/L, HbA1c ≥48 mmol/mol, a random plasma glucose ≥11.1 mmol/L in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose ≥7.0 mmol/L and/or 2 hour plasma glucose ≥11.1 mmol/L.

Locations
Other Locations
Denmark
Department of Gastroenterology and Hepatology, Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Maja Thiele, MD, PhD, Professor
maja.thiele@rsyd.dk
+4524998068
Time Frame
Start Date: 2017-10-06
Estimated Completion Date: 2035-10-30
Participants
Target number of participants: 6500
Treatments
Experimental: Liver stiffness measurement
Transient elastography in fasting state
Sponsors
Collaborators: University of Southern Denmark, Odense Municipality Alcohol Rehabilitation Unit, Steno Diabetes Center Copenhagen, Esbjerg University Hospital of South-West Jutland, Manatee APS, Svendborg Municipality Alcohol Rehabilitation Unit, Siemens Healthcare A/S, University of Copenhagen, European Molecular Biology Laboratory, EMBL, University of Heidelberg, University of Oslo, Nordic Bioscience A/S, Horizon 2020 - European Commission, Novo Nordisk A/S, VLV Bio, Peviva AB, Biomedical Research Foundation, Academy of Athens
Leads: Maja Thiele

This content was sourced from clinicaltrials.gov