Since progression from NAFLD to NASH is associated with significantly increased risk of morbidity and mortality, there is a clinical imperative to identify the NAFLD patients that rapidly progress to NASH from those who will remain in the NAFLD…
Brief title
Health condition
NAFLD, NASH
Sponsors and support
Intervention
Outcome measures
Primary outcome
to identify and validate noninvasive diagnostic methods (imaging and molecular markers) in disease progression from NAFLD to NASH as well as progression of NASH itself
Secondary outcome
to apply a systems biology approach to identify the hierarchy of driving mechanisms (microbial and metabolic markers) involved in the conversion of NAFLD-NASH and NASH-cirrhosis after 5 years
Background summary
Our study aims to identify novel risk factors in subjects with hepatic steatosis, as well as to validate noninvasive imaging modalities, in order to better discern the patients who progress to NASH from non-progressing NAFLD patients. Our rigorous baseline biomarker validation against biopsy proven NAFLD-NASH progression over 5 years has the goal to reduce the need for future liver biopsies in NAFLD-NASH in the clinical setting.
Study objective
Since progression from NAFLD to NASH is associated with significantly increased risk of morbidity and mortality, there is a clinical imperative to identify the NAFLD patients that rapidly progress to NASH from those who will remain in the NAFLD stage, in order to better monitor these patients and to reduce their metabolic risk. Our study aims to identify novel risk factors in subjects with hepatic steatosis, as well as to validate noninvasive imaging modalities, in order to better discern the patients who progress to NASH from non-progressing NAFLD patients. Our rigorous baseline biomarker validation against biopsy proven NAFLD-NASH progression over 5 years has the goal to reduce the need for future liver biopsies in NAFLD-NASH in the clinical setting. As there are currently no registered treatment modalities for NASH besides dietary intervention, improved understanding of the pathophysiological mechanisms as well as their relationship to metabolic disturbances are of crucial importance to discover new diagnostic and therapeutical targets in NAFLD/NASH.
Study design
0 and 5 years
Intervention
Ultrasound guided liver biopsy
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Inclusion criteria
• Diagnosis of steatosis hepatis on ultrasound or by biopsy
• >18 years of age
• Transaminases ALAT and ASAT above upper limit (50U/L)
• BMI > 30 kg/ m²
Exclusion criteria
• Abusive alcohol use (>20 IU/week)
• Hepatitis B and/or C
• Auto-immune hepatitis
• Wilsons disease/ alpha-1-antitripsine deficiency
• Hemochromatosis
• Bleeding disorder
• Use of drugs with a potential role in aggravation of pre-existing NAFLD
• Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker)
• Diagnosis of liver cirrhosis and/or hepatocellular carcinoma
Design
Recruitment
(Historical) registrations known in this register
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7001 |
| NTR-old | NTR7191 |
| CCMO | NL 63975.018.17 |