ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	3 August 2015
Main ID:	NCT02488941
Date of registration:	17/06/2015
Prospective Registration:	No
Primary sponsor:	University of Aarhus
Public title:	Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
Scientific title:	Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
Date of first enrolment:	June 2015
Target sample size:	30
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02488941
Study type:	Observational
Study design:	Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	Marianne Vonsild
Address:
Telephone:	+45 7846 3892
Email:	marianne.vonsild@clin.au.dk
Affiliation:

Name:	Peter Lykke Eriksen, MD
Address:
Telephone:	+45 7846 4076
Email:	ple@clin.au.dk
Affiliation:

Name:	Hendrik Vilstrup, Professor
Address:
Telephone:
Email:
Affiliation:	Department of Hepatology & Gastroenterology, Aarhus University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18

- Hepatic steatosis found on ultrasound

- Clinical indication for liver biopsy (typically persistently elevated alanine
transaminase (ALT) levels)

Exclusion Criteria:

- Other liver pathology

- Alcohol consumption > 20g/day

- Chronic inflammatory disease, current infection or cancer

- Diabetes mellitus type I, II or HbA1c = 48 mmol/mol (6.5 %)

- Prednisolone treatment within last 8 weeks

- Pregnancy within last 12 months

- Contraindication for MRI

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-alcoholic Fatty Liver Disease

Intervention(s)

Primary Outcome(s)

Regional fat infiltration assessed by MRI [Time Frame: Baseline]

Metabolic Liver Function assessed by ABT [Time Frame: Baseline]

Metabolic Liver Function assessed by FHNC [Time Frame: Baseline]

Metabolic Liver Function assessed by ICG-PDR [Time Frame: Baseline]

Regional metabolic liver function evaluated by FDGal PET/CT [Time Frame: Baseline]

Metabolic Liver Function assessed by GEC [Time Frame: Baseline]

Secondary Outcome(s)

Primary hemostasis [Time Frame: Baseline]

Secondary hemostasis [Time Frame: Baseline]

Natural anti-coagulants [Time Frame: Baseline]

Fibrinolysis [Time Frame: Baseline]

Secondary ID(s)

Metabolic liver function NAFLD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.