1. To identify a biomarker of hepatic DNL in different disease models of NAFLD. 2. To assess the cardiovascular risk profile in the different disease models of NAFLD.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Inborn errors of metabolism
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a set of candidate biomarkers of DNL measured in plasma
Secondary outcome
Secondary outcome: endothelial function (reactive hyperaemia peripheral
applanation tonometry, laser doppler flowmetry and plasma biomarkers)
Other parameters: hepatic fat accumulation (magnetic resonance spectroscopy)
and fat distribution (MRI)
Background summary
Epidemiological studies have demonstrated that non-alcoholic fatty liver
disease (NAFLD) is associated with cardiovascular disease. Subsequent studies
have suggested that hepatic de novo lipogenesis (DNL), i.e. de conversion of
glucose to fat, is responsible for this association. However, there is
currently no good biomarker of DNL that can be used to confirm this hypothesis
in large epidemiological cohorts.
Study objective
1. To identify a biomarker of hepatic DNL in different disease models of NAFLD.
2. To assess the cardiovascular risk profile in the different disease models of
NAFLD.
Study design
Observational study with a cross-sectional design.
Study burden and risks
The risks of this study are minimal, since no interventions are imposed. The
only invasive test is blood withdrawal (150 ml in total; 165 ml for GSD1a
patients), which is associated with minimal health risk. Subjects will undergo
a screening for NAFLD, type 2 diabetes mellitus and cardiovascular risk, which
may be of potential benefit.
P Debyelaan 25
Maastricht 6229 HX
NL
P Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Healthy individuals:
- age ><= 18 years, NAFLD disease models (n<=15 per group):
- diagnosis of glycogen storage disease 1a (GSD1a), familial partial
lipodystrophy (FPL), maturity-onset diabetes of the young type 2 (MODY2) or
abetalipoproteniemia/familial hypobetalipoproteinemia
- age ><= 18 years
Exclusion criteria
- Contraindications for MRI (i.e. claustrophobia, heart pacemaker or other
electronic devices implanted in the body, history of collapse or seizure, or
pregnancies < 12 weeks)
- Inability to give inform consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63134.068.17 |