REFErence Repository for healthy livers (REFER trial)

Recruiting

Conditions: gallstones, NAFLD, Liver disease

Registration Number: NL-OMON28065

Lead Sponsor: AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

18-65 years of age
-BMI < 30 kg/m2
-Individual should be able to give informed consent

Exclusion Criteria

-Type 2 diabetes mellitus
-Prior bariatric surgery
-Inflammatory bowel disease
-Primary lipid disorder
-Known genetic basis for insulin resistance or glucose intolerance
-Ethanol intake > 2 U/week
-Pregnancy, females who are breastfeeding
-Hepatitis B and/or C
-Liver cirrhosis
-Auto-immune hepatitis
-Wilson disease3/ alpha 1-antitripsine deficiency
-Hemochromatosis

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Presence of NAFLD/NASH parameters in liver biopsy using histology (NASH-CRN / Steatosis Activity and Fibrosis Score Steatosis) and liver RNA sequencing.

Secondary Outcome Measures

Name	Time	Method
1.Presence of bacterial DNA, histology and inflammatory genes (RNA seq) liver and abdominal adipose tissue depots as well as metabolites in plasma, feces and urine<br>2.Fecal and oral microbiota composition <br>3.Dietary, psychological and satiety lists and excreted metabolites<br>4.Clinical data (body weight, body composition), waist circumference and blood pressure<br>5.Genomic DNA (buffy coat)<br>