AzTrials
AzTrials

Non-Alcoholic Fatty Liver DiseaseNCT03260036

Hepatic Urea Nitrogen Handling in Patients With NASH

An observational study of Non-Alcoholic Fatty Liver Disease, run by University of Aarhus at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
How many people
20 participants
Where
1 siteDenmark
Study dates
21 Aug 2017to 21 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Obese patients referred for bariatric surgery

Who may be able to join

  • 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

Who cannot join

  • Chronic inflammatory diseases
  • Acute severe bacterial infection (sepsis, pneumonia, urinary tract infection etc.)
  • Cancer
  • Neurological diseases
  • Prednisolone treatment within the last 8 weeks
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Department of Hepatology and Gastroenterology, Aarhus University Hospital

    Aarhus, 8000

Other trials in Denmark

About this study

Official title: The Effect of Bariatric Surgery on Hepatic Urea Nitrogen Handling and Cognitive Functions in Patients With Severe Non-alcoholic Fatty Liver Disease

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).

Read the detailed description

NAFLD is the most common cause of chronic liver disease in the western world affecting 10-30% of the general population. It is strongly associated with the metabolic syndrome caused by overweight and obesity. NAFLD is a spectrum of liver disease ranging from steatosis (hepatocytic fat accumulation occurs without hepatocellular injury), to non-alcoholic steatohepatitis (NASH) (steatosis is accompanied by inflammation and hepatocyte injury with or without fibrosis) and to cirrhosis in patients that are not consuming excessive alcohol. The prognosis of patients with simple steatosis appears benign whereas NASH often has a progressive course with increased liver-related morbidity and mortality.

Patients with liver disease often have impairment of metabolic liver functions. The liver has numerous functions, which are essential for maintenance of life e.g. urea synthesis. This function is central in whole body nitrogen (N) homeostasis and removes ammonia, which is produced during N conversion and is extremely toxic especially for brain functions. Impairment of urea synthesis causes increased ammonia concentrations in the blood, which is taken up by the brain and contributes to development of hepatic encephalopathy in patients with liver disease. This condition is one of the most debilitating complications of liver disease as it affects cognitive functions and with increasing severity also behaviour and motor function. The mild stage (termed minimal hepatic encephalopathy) causes subtle cognitive dysfunction, which can only be detected by means of special tests. The more severe stages (manifest hepatic encephalopathy) are accompanied by manifest dysfunction of sleep pattern and orientation eventually leading to liver coma. The condition is reversible and no structural brain damage occurs.

We seek to investigate the consequences of bariatric surgery on liver and brain function with a special focus on NASH patients. The investigations will comprise examination of the capacity for urea synthesis and various psychometric and neurophysiological tests to evaluate the patient's cognitive functions before and 18 months after surgery.

A liver biopsy will be availed at the time of surgical intervention and genetic and functional characterization of urea cycle enzymes will be performed to correlate with histological scores, clinical disease staging and ammonia/capacity for urea synthesis. A further liver biopsy will be performed after 18 months to determine if there has been any change in NAFLD disease stage and urea cycle enzymes after intervention.

Keywords
Urea synthesis, Ammonia, Bariatric surgery
Medical subject headings
Non-alcoholic Fatty Liver Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline and 18 months

Secondary outcomes (5)
  1. Urea cycle enzymes (protein and gene level)

    Examined in liver biopsy

    Measured: Baseline and 18 months

  2. Changes in The Portosystemic Encephalopathy Syndrome-Test

    To evaluate changes in the patient's cognitive functions

    Measured: Baseline and 18 months

  3. Changes in Continuous Reaction Time Test

    To evaluate changes in the patient's cognitive functions

    Measured: Baseline and 18 months

  4. Changes in Critical Flicker Frequency

    To evaluate changes in the patient's cognitive functions

    Measured: Baseline and 18 months

  5. Changes in EEG

    To evaluate potential changes in the patient's EEG

    Measured: Baseline and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start21 Aug 2017
  3. Primary completion21 Aug 2025 (estimated)
  4. Study completion21 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03260036
Sponsor's protocol ID
FHNC-bariatric
Status last verified
Jun 2023
First submitted
16 Aug 2017
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Alcoholic Fatty Liver Disease, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Functional Hepatic Nitrogen Clearance (FHNC) (time frame: Baseline and 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in