Status:
UNKNOWN
Metabolic Surgery for Steato-Hepatitis
Lead Sponsor:
King's College London
Conditions:
Non-alcoholic Fatty Liver Disease (NAFLD)
Non-Alcoholic Steato-Hepatitis (NASH)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is associated with obesity and type 2 diabetes mellitus (T2DM) and is characterised by excess liver fat on imaging or histology. NAFLD affects up to 25% of th...
Detailed Description
This study's population includes patients with severe obesity (BMI \>35kg/m2 or \>32.5. kg/m2 if patient of South Asian, Caribbean or Black ethnicity) and non-alcoholic fatty liver disease (NAFLD) who...
Eligibility Criteria
Inclusion
- • BMI greater than 35 kg/m2 (or \>32.5. kg/m2 for patients of South Asian, Caribbean or Black ethnicities) with raised alanine transaminase (ALT), aspartate transaminase (AST) and a FibroScan® score \> 7.9 (indicating presence of NAFLD and high likelihood of NASH).
Exclusion
- other causes of liver disease such as viral, alcoholic (alcohol consumption \>20 g/day for women or \>30 g/day for men),
- auto-immune disease
- use of certain medications that may interfere with outcome measures (i.e. corticosteroids, insulin and glycoprotein-1 (GLP-1) analogues).
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04282005
Start Date
February 13 2020
End Date
January 1 2022
Last Update
March 5 2020
Active Locations (1)
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1
King's College London
London, United Kingdom