Postprandial FGF-19 response after fat challenge in patients with cholestatic liver disease

• Conditions: primary biliary cirrhosis and primary sclerosing cholangitis; 10017969; 10019654

• Registration Number: NL-OMON34548
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

Age 18-75 years old. Primary biliary cirrhosis (12), primary sclerosing cholangitis (12) diagnosed preliminary and independent of this study by liverbiopsy (PBC) or MRI (PSC) and 12 patients with IBD without PSC/PBC. 12 healthy subjects.

Exclusion Criteria

Exclusion of other liver diseases, defined as:
- HBsAg and HCV-antibodies positive
- autoimmune hepatitis (ANA, SMA and AMA positive)
- hemochromatosis (abnormal iron-saturation)
- no Wilson's disease (abnormal ceruloplasmine)
- alcohol intake >2 units/day.
Previous ileocecal resection.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Plasma levels of FGF-19, plasma markers of bile acid synthesis (as a measure<br /><br>of suppression of Cyp7A1, a hepatic target gene of FGF19) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>