Ignite Creation Date:
2024-05-06 @ 4:18 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04946786
Status:
UNKNOWN
Last Update Posted:
2021-07-01
First Post:
2021-06-13
Brief Title:
Clinical Biochemical and Body Composition Analysis in Assessment of Steatosis in Non Alcoholic Fatty Liver Disease
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Role of Clinical Biochemical and Body Composition Analysis in Assessment of Steatosis in Patients With Non Alcoholic Fatty Liver Disease
Status:
UNKNOWN
Status Verified Date:
2021-06
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:
Non-alcoholic fatty liver disease NAFLD includes a spectrum of liver disorders characterized by accumulation of hepatic fat in absence of significant alcohol consumption 20 gmday and other causes of liver diseases It is the most common cause of asymptomatic elevation of liver enzymes worldwide Marchesini et al 2003
Unfortunately to date existing non- or minimally invasive biomarkers are inadequate While a number of non- or minimally invasive tests are able to rule out fibrosis or cirrhosis no single test to identify steatosis to early diagnose NASH or to predict the disease progression is available Moreover specialized combined tests are required to assess treatment response in clinical trials on emerging compounds Piazzolla and Mangia 2020
Among minimally invasive tools plasma biomarkers and composite scores defined as wet biomarkers are commonly used For example fasting insulin level and its use in measurement of insulin resistance Lipid Accumulation Product LAP score Bedogni et al 2010 the NAFLD Liver Fat Score NLFS Kontronen et al 2009 Hepatic Steatosis Index HSI Lee et al 2010 controlled attenuation parameter CAP measurement by fibroscan Piazzolla and Mangia 2020 Recent studies have shown that CAP significantly correlates with the percentage of steatosis and steatosis grade and that median CAP is higher among patients with significant steatosis Sasso et al 2012 Karlas et al 2017
The prevalence of NAFLD is 80-90 in obese 30-50 in patients with diabetes and up to 90 in patients with hyperlipidemia Abenavoli et al 2014
Central obesity or visceral fat VF determined by waist circumference WC is defined as the presence of excess fat in the abdomen and this type of obesity is often associated with the development and progression of NAFLD or more advanced forms of liver disease Abenavoli et al 2016 Thus measurement of body composition rather than BMI may be helpful in the prediction of NAFLD Milić et al 2014 and Abenavoli et al 2016
There is a growing need to assess the steatosis in NAFLD patients using minimally invasive tools
Unfortunately to date existing non- or minimally invasive biomarkers are inadequate While a number of non- or minimally invasive tests are able to rule out fibrosis or cirrhosis no single test to identify steatosis to early diagnose NASH or to predict the disease progression is available Moreover specialized combined tests are required to assess treatment response in clinical trials on emerging compounds Piazzolla and Mangia 2020
Among minimally invasive tools plasma biomarkers and composite scores defined as wet biomarkers are commonly used For example fasting insulin level and its use in measurement of insulin resistance Lipid Accumulation Product LAP score Bedogni et al 2010 the NAFLD Liver Fat Score NLFS Kontronen et al 2009 Hepatic Steatosis Index HSI Lee et al 2010 controlled attenuation parameter CAP measurement by fibroscan Piazzolla and Mangia 2020 Recent studies have shown that CAP significantly correlates with the percentage of steatosis and steatosis grade and that median CAP is higher among patients with significant steatosis Sasso et al 2012 Karlas et al 2017
The prevalence of NAFLD is 80-90 in obese 30-50 in patients with diabetes and up to 90 in patients with hyperlipidemia Abenavoli et al 2014
Central obesity or visceral fat VF determined by waist circumference WC is defined as the presence of excess fat in the abdomen and this type of obesity is often associated with the development and progression of NAFLD or more advanced forms of liver disease Abenavoli et al 2016 Thus measurement of body composition rather than BMI may be helpful in the prediction of NAFLD Milić et al 2014 and Abenavoli et al 2016
There is a growing need to assess the steatosis in NAFLD patients using minimally invasive tools
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None