NAFLD non-alcoholic fatty liver disease
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. Clinically suspected NAFLD based on any of: a. Patient with historical liver biopsy providing histological evidence of NAFLD or, b. Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or, c. Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of >=2 features indicative of the *metabolic syndrome*: i. Increased waist circumference by ethnically adjusted criteria (e.g. Europid male/female >=94cm/80cm) or overweight/obese (BMI >=25); ii. 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); iii. Dyslipidaemia (fasting TG level >=150 mg/dL [1.7 mmol/L]; or fasting HDL =130 or diastolic BP >=85 mmHg, or on treatment). 3. 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
Exclusion criteria: 1. Refusal or inability (lack of capacity) to give informed consent. 2. 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. 3. History or presence of Type 1 diabetes mellitus. 4. Presence of any other form of chronic liver disease except NAFLD. 5. 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). 6. Any contra-indication to liver biopsy. 7. 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. 8. Non-Dutch speaking/unable to access an interpreter. Due to the nature of the study, Dutch language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated. 9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Cross-sectional correlation of clinical phenotype data with blood-based biomarkers (genetic, epigenetic, transcriptomic, metabolomics, proteomic and metagenomic) and/or imaging biomarkers to develop and validate optimum biomarker approaches for the diagnosis and risk stratification of NAFLD. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Longitudinal correlation of clinical phenotype data with blood-based biomarkers (genetic, epigenetic, transcriptomic, metabolomics, proteomic and metagenomic) and/or imaging biomarkers to develop and validate optimum biomarker approaches for the diagnosis, risk stratification and monitoring of NAFLD. • Study of dietary habits and lifestyle factors (sedentary behaviour/exercise levels) in patients with NAFLD; • Study of symptom burden in patients with NAFLD to develop and validate a new disease-specific Patient Reported Outcome Measure (PROM) for NAFLD. • Study the underlying pathogenic processes contributing to disease progression in NAFLD: o Conduct of candidate gene and genome-wide disease association studies (GWAS) to identify genetic variants influencing disease severity in NAFLD; o Analysis of circulating miRNA, mRNA and DNA methylation (mDNA) profiles in the liver and/or blood of patients with NAFLD; o Study of the blood lipid/metabolic/proteomic profiles of patients with NAFLD; o Study of the intestinal bacterial flora of patients with NAFLD; | — |
Countries
Netherlands
Outcome results
None listed