NCT03260036

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

August 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2025

Completed
Last Updated

May 14, 2024

Status Verified

June 1, 2023

Enrollment Period

8 years

First QC Date

August 16, 2017

Last Update Submit

May 13, 2024

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Urea synthesisAmmoniaBariatric surgery

Outcome Measures

Primary Outcomes (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

    Baseline and 18 months

Secondary Outcomes (5)

  • Urea cycle enzymes (protein and gene level)

    Baseline and 18 months

  • Changes in The Portosystemic Encephalopathy Syndrome-Test

    Baseline and 18 months

  • Changes in Continuous Reaction Time Test

    Baseline and 18 months

  • Changes in Critical Flicker Frequency

    Baseline and 18 months

  • Changes in EEG

    Baseline and 18 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese patients referred for bariatric surgery

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue Blood

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Karen Louise Thomsen, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 24, 2017

Study Start

August 21, 2017

Primary Completion

August 21, 2025

Study Completion

August 21, 2025

Last Updated

May 14, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)