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REFErence Repository for healthy livers (REFER trial)

REFErence Repository for healthy livers (REFER trial)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28065
Enrollment
200
Registered
2020-10-06
Start date
2020-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

gallstones, NAFLD, Liver disease

Interventions

None listed

Sponsors

AMC
Lead Sponsor

Eligibility

Inclusion criteria

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

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

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

Secondary

MeasureTime 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, psychological and satiety lists and excreted metabolites 4. Clinical data (body weight, body composition), waist circumference and blood pressure 5. Genomic DNA (buffy coat)

Contacts

Public ContactStijn Meijnikman

Amsterdam UMC locatie AMC

a.s.meijnikman@amsterdamumc.nl0205661925

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)