REFErence Repository for healthy livers

REFErence Repository for healthy livers - REFER

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49481

Enrollment

200

Registered

2020-09-02

Start date

2020-11-12

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Galsteenlijden Fatty Liver Disease Non-Alcoholic Fatty liver Disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18-65 years of age - BMI

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
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 2. Fecal and oral microbiota composition 3. Dietary, psychology and satiety lists and excreted metabolites 4. Clinical data (body weight and composition), waist circumference and blood pressure 5. Genomic DNA (buffy coat) 6. 7. Gallbladder tissue and bile acid collection after cholecystectomy surgery	—

Measure

Time frame

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 2. Fecal and oral microbiota composition 3. Dietary, psychology and satiety lists and excreted metabolites 4. Clinical data (body weight and composition), waist circumference and blood pressure 5. Genomic DNA (buffy coat) 6. 7. Gallbladder tissue and bile acid collection after cholecystectomy surgery

—

Countries

Netherlands

Outcome results