REFErence Repository for healthy livers

Recruiting

Conditions: Galsteenlijden
Fatty Liver Disease
Non-Alcoholic Fatty liver Disease

Registration Number: NL-OMON49481

Lead Sponsor: Academisch Medisch Centrum

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 invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine differences in omics data sets of several biological layers<br /><br>between men and women with<br /><br>and without NAFLD and investigate to what extent these signatures contribute to<br /><br>NAFLD development.<br /><br>Therefore, we will establish a reference repository of healthy liver biopsies<br /><br>to establish an integrative<br /><br>signature of healthy and diseased (NAFLD) liver metabolism in men and women. To<br /><br>this end we will<br /><br>collect on the day of surgery the following parameters.<br /><br><br /><br>1. Presence of NAFLD/NASH parameters in liver biopsy using histology (NASH-CRN<br /><br>/ Steatosis Activity and Fibrosis Score)8 and liver RNA sequencing </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Presence of bacterial DNA, histology and inflammatory genes (RNA seq) liver<br /><br>and abdominal adipose tissue depots as well as metabolites in plasma, feces and<br /><br>urine<br /><br>2. Fecal and oral microbiota composition<br /><br>3. Dietary, psychology and satiety lists and excreted metabolites<br /><br>4. Clinical data (body weight and composition), waist circumference and blood<br /><br>pressure<br /><br>5. Genomic DNA (buffy coat)<br /><br>6. 7. Gallbladder tissue and bile acid collection after cholecystectomy surgery</p><br>