Phase
Condition
Stress
Liver Cancer
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years.
Clinically suspected NAFLD based on any of:
Patient with historical liver biopsy providing histological evidence of NAFLD or,
Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or,
Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome':
Increased waist circumference by ethnically adjusted criteria (e.g. Europid male/female ≥94cm/80cm) or overweight/obese (BMI ≥25);
Raised fasting glucose ≥100 mg/dL [5.6 mmol/L], HbA1c ≥48mmol/mol (6.5%) or previously diagnosed insulin resistance/type 2 diabetes mellitus (or on treatment);
Dyslipidaemia (fasting TG level ≥150 mg/dL [1.7 mmol/L]; or fasting HDL <40 mg/dL [1.03 mmol/L] in males and <50 mg/dL [1.29 mmol/L] in females; or on treatment);
Hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on treatment).
- Average alcohol consumption less than 21/14 units/week (males/females) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.
Exclusion Criteria
Refusal or inability (lack of capacity) to give informed consent.
Average alcohol ingestion greater than approximately 21/14 units/week (males/females) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
History or presence of Type 1 diabetes mellitus.
Presence of any other form of chronic liver disease except NAFLD.
Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).
Any contra-indication to liver biopsy.
Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.
Non-English speaking/unable to access an interpreter. Due to the nature of the study, English language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated.
Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.
Study Design
Study Description
Connect with a study center
Universitair Ziekenhuis Antwerpen
Antwerp,
BelgiumActive - Recruiting
Helsinki University Hospital
Helsinki,
FinlandActive - Recruiting
Le Centre de Recherche Clinique (CRC) du CHU d'Angers
Angers, 49933
FranceActive - Recruiting
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
Paris, 75013
FranceActive - Recruiting
UNIVERSITÄTSKLINIKUM der RWTH Aachen
Aachen, 52074
GermanySite Not Available
Charité University Hospital Berlin
Berlin,
GermanySite Not Available
Universitätsklinikum Freiburg
Freiburg, 79106
GermanySite Not Available
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
Mainz, 55131
GermanyActive - Recruiting
Universitätsklinikums Würzburg
Würzburg, D-97080
GermanyActive - Recruiting
Laiko General Hospital of Athens
Athens, 11527
GreeceActive - Recruiting
Polytechnic University of Marche
Ancona,
ItalyActive - Recruiting
Università degli Studi Milano
Milan,
ItalyActive - Recruiting
Università di Palermo
Palermo,
ItalyActive - Recruiting
Università Cattolica del Sacro Cuore
Rome,
ItalyActive - Recruiting
Department of Medical Sciences University of Torino
Turin,
ItalyActive - Recruiting
Amsterdam UMC
Amsterdam,
NetherlandsActive - Recruiting
Hospital de Santa Maria
Lisboa,
PortugalActive - Recruiting
Vall d'Hebron University Hospital
Barcelona,
SpainActive - Recruiting
Biodonostia Health Research Institute
Donostia,
SpainActive - Recruiting
Puerta de Hierro University Hospital
Majadahonda,
SpainActive - Recruiting
Marqués de Valdecilla University Hospital
Santander,
SpainActive - Recruiting
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital
Sevilla,
SpainActive - Recruiting
HU Clínico de Valladolid
Valladolid,
SpainActive - Recruiting
Karolinska Universitetssjukhuset
Huddinge,
SwedenActive - Recruiting
Linköping University Hospital
Linköping,
SwedenActive - Recruiting
Inselspital, University Hospital
Bern,
SwitzerlandActive - Recruiting
University Hospitals Birmingham Nhs Foundation Trust
Birmingham,
United KingdomActive - Recruiting
Addenbrooke'S Hospital
Cambridge,
United KingdomActive - Recruiting
Queen Elizabeth Hospital
Gateshead,
United KingdomSite Not Available
Hull Royal Infirmary
Hull,
United KingdomActive - Recruiting
Royal London Hospital, Barts Health NHS Trust
London,
United KingdomActive - Recruiting
St George's University Hospitals
London,
United KingdomActive - Recruiting
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle-upon Tyne, NE7 7DN
United KingdomActive - Recruiting
Queen'S Medical Centre
Nottingham,
United KingdomActive - Recruiting
Oxford University Hospitals Nhs Foundation Trust
Oxford,
United KingdomActive - Recruiting
Derriford Hospital
Plymouth,
United KingdomActive - Recruiting
Queen Alexandra Hospital
Portsmouth,
United KingdomActive - Recruiting

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