Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
The Effect of Bariatric Surgery on Hepatic Urea Nitrogen Handling and Cognitive Functions in Patients With Severe Non-alcoholic Fatty Liver Disease
Verified date | June 2023 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the project is to investigate the metabolic regulation of the hepatic urea nitrogen handling and various cognitive functions measured by psychometric and neurophysiological tests before and after bariatric surgery in patients with non-alcoholic fatty liver disease (NAFLD).
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | August 21, 2025 |
Est. primary completion date | August 21, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Referred for bariatric surgery (BMI > 40 kg/m2 or BMI > 35 kg/m2 and obesity-related complications - Steatosis on ultrasound (US) - Alcohol intake < 40g/day - Exclusion of other liver diseases Exclusion Criteria: - Chronic inflammatory diseases - Acute severe bacterial infection (sepsis, pneumonia, urinary tract infection etc.) - Cancer - Neurological diseases - Prednisolone treatment within the last 8 weeks - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Hepatology and Gastroenterology, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Functional Hepatic Nitrogen Clearance (FHNC) | FHNC is a validated method for assessing the conversion of amino-nitrogen to urea-nitrogen by the liver | Baseline and 18 months | |
Secondary | Urea cycle enzymes (protein and gene level) | Examined in liver biopsy | Baseline and 18 months | |
Secondary | Changes in The Portosystemic Encephalopathy Syndrome-Test | To evaluate changes in the patient's cognitive functions | Baseline and 18 months | |
Secondary | Changes in Continuous Reaction Time Test | To evaluate changes in the patient's cognitive functions | Baseline and 18 months | |
Secondary | Changes in Critical Flicker Frequency | To evaluate changes in the patient's cognitive functions | Baseline and 18 months | |
Secondary | Changes in EEG | To evaluate potential changes in the patient's EEG | Baseline and 18 months |
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