Ignite Creation Date:
2024-05-06 @ 8:20 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02717000
Status:
UNKNOWN
Last Update Posted:
2016-03-23
First Post:
2016-03-15
Brief Title:
NASH Non-invasive Diagnostic Markers and Imaging
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Patients With Non-alcoholic Fatty Liver Disease Using Markers and Imaging Techniques
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale
Non-alcoholic fatty liver disease NAFLD is the most widespread liver disorder in Western society prevalence 20-30 It is strongly associated with overweight and obesity The majority of patients have simple steatosis However in about 15-30 of the subjects a chronic inflammatory state develops that is referred to as non-alcoholic steatohepatitis NASH which leads to an overall increase in morbidity and mortality due to the progression to fibrosis cirrhosis and in some cases hepatocellular carcinoma HCC The term NAFLD comprises both simple steatosis and NASH Most patients with NAFLD have no or few mainly aspecific symptoms and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality
To date liver biopsy is the most sensitive test for detecting and staging NAFLD and is the only reliable method for differentiating between NASH and simple steatosis However the procedure of obtaining a liver biopsy is invasive and associated with patient discomfort significant complications and high costs In addition liver biopsy is prone to sampling error and inter- and intra-observer variability due to the small size of liver biopsy samples This method is therefore not suitable for screening large numbers of subjects at risk or for follow-up of patients with NASH over time Hence only subjects at high risk usually based upon elevated aminotransferase levels which is not specific for the presence of NASH are biopsied leading to an underestimation of NASH prevalence and undertreatment Further insight into disease mechanisms and risk factors for NAFLD and in particular NASH is warranted to enable early diagnosis adequate therapy and preventive measures to improve health status of these individuals Accurate and less invasive methods to evaluate NASH and NAFLD are urgently needed
Objective The primary objective of this study is to establish non-invasive tools eg biomarkers and imaging to accurately diagnose patients with NASH The secondary objective is to show an association between the levels of identified markers and disease severity
Study design
Eligible subjects will be included via the outpatient clinics Zuyderland in Heerlen the Catharina hospital in Eindhoven and MUMC in Maastricht A subset of eligible subjects has undergone a liver biopsy for clinical reasons It is estimated that about 85 of subjects will be asked to undergo a biopsy for study purposes only Liver biopsies for study purposes will be performed during a surgical procedure eg bariatric surgery or cholecystectomy
Blood faeces and exhaled air will be collected and a FibroScan CAP will be performed during a study visit An MRI will be performed to estimate the degree of steatosis Furthermore anthropometric data weight height abdominal and waist circumference and blood pressure BP will be collected
The participants in the group undergoing liver biopsy during bariatric surgery will be asked permission to be approached for follow-up measurements 3 months post-surgery As they will lose weight which is associated with improvement of hepatic steatosis this enables assessment of possible changes over time A routine follow-up visit post-surgery will take place after 3 months The follow-up measurements will be combined with this visit minimizing the burden for the participant The measurements will consist of blood faeces and exhaled air collection and a FibroScan CAP will be performed during a study visit Furthermore weight height BP and abdominal and waist circumference will be measured
Study population
Subjects with proven NAFLD by histology or NAFLD proven by imaging who are undergoing surgery ie bariatric surgery or cholecystectomy will be asked to participate in this study Furthermore all subjects have to be between 18 and 65 years old
Main study parametersendpoints
Non-invasive tool based on biomarkers and imaging to diagnose NASH
Non-alcoholic fatty liver disease NAFLD is the most widespread liver disorder in Western society prevalence 20-30 It is strongly associated with overweight and obesity The majority of patients have simple steatosis However in about 15-30 of the subjects a chronic inflammatory state develops that is referred to as non-alcoholic steatohepatitis NASH which leads to an overall increase in morbidity and mortality due to the progression to fibrosis cirrhosis and in some cases hepatocellular carcinoma HCC The term NAFLD comprises both simple steatosis and NASH Most patients with NAFLD have no or few mainly aspecific symptoms and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality
To date liver biopsy is the most sensitive test for detecting and staging NAFLD and is the only reliable method for differentiating between NASH and simple steatosis However the procedure of obtaining a liver biopsy is invasive and associated with patient discomfort significant complications and high costs In addition liver biopsy is prone to sampling error and inter- and intra-observer variability due to the small size of liver biopsy samples This method is therefore not suitable for screening large numbers of subjects at risk or for follow-up of patients with NASH over time Hence only subjects at high risk usually based upon elevated aminotransferase levels which is not specific for the presence of NASH are biopsied leading to an underestimation of NASH prevalence and undertreatment Further insight into disease mechanisms and risk factors for NAFLD and in particular NASH is warranted to enable early diagnosis adequate therapy and preventive measures to improve health status of these individuals Accurate and less invasive methods to evaluate NASH and NAFLD are urgently needed
Objective The primary objective of this study is to establish non-invasive tools eg biomarkers and imaging to accurately diagnose patients with NASH The secondary objective is to show an association between the levels of identified markers and disease severity
Study design
Eligible subjects will be included via the outpatient clinics Zuyderland in Heerlen the Catharina hospital in Eindhoven and MUMC in Maastricht A subset of eligible subjects has undergone a liver biopsy for clinical reasons It is estimated that about 85 of subjects will be asked to undergo a biopsy for study purposes only Liver biopsies for study purposes will be performed during a surgical procedure eg bariatric surgery or cholecystectomy
Blood faeces and exhaled air will be collected and a FibroScan CAP will be performed during a study visit An MRI will be performed to estimate the degree of steatosis Furthermore anthropometric data weight height abdominal and waist circumference and blood pressure BP will be collected
The participants in the group undergoing liver biopsy during bariatric surgery will be asked permission to be approached for follow-up measurements 3 months post-surgery As they will lose weight which is associated with improvement of hepatic steatosis this enables assessment of possible changes over time A routine follow-up visit post-surgery will take place after 3 months The follow-up measurements will be combined with this visit minimizing the burden for the participant The measurements will consist of blood faeces and exhaled air collection and a FibroScan CAP will be performed during a study visit Furthermore weight height BP and abdominal and waist circumference will be measured
Study population
Subjects with proven NAFLD by histology or NAFLD proven by imaging who are undergoing surgery ie bariatric surgery or cholecystectomy will be asked to participate in this study Furthermore all subjects have to be between 18 and 65 years old
Main study parametersendpoints
Non-invasive tool based on biomarkers and imaging to diagnose NASH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None