Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04660409
Status:
UNKNOWN
Last Update Posted:
2020-12-09
First Post:
2020-11-24
Brief Title:
Assessment of the Correlation Between Serum Levels of Adropin and Degree of Severity of Chronic Liver Disease
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Assessment of the Correlation Between Serum Levels of Adropin and Degree of Severity of Chronic Liver Disease
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
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:
Injury to the liver parenchyma associated with an influx of acute or chronic inflammatory cells is termed hepatitis Cirrhosis refers to a progressive diffuse fibrosing nodular condition that disrupts the entire normal architecture of the liver Patients with chronic liver disease have sustained hepatic inflammation fibrosis and aberrant hepatocyte regeneration These abnormalities can cause cirrhosis and favor a series of genetic and epigenetic events that culminate in the formation of dysplastic nodules which are actually preneoplastic lesions Hepatocellular carcinoma can also arise in patients who have chronic liver disease but does not have established cirrhosis or marked inflammation
The gold standard for evaluation and follow up of liver fibrosis and cirrhosis is liver biopsy Its a costly procedure with risks of severe complications with sampling error and problematic long term follow up Non-invasive tools are broadly used with good results but none of the commonly used methods is perfect In one meta-analysis different methods were compared for diagnosis of cirrhosis in Non-alcoholic fatty liver disease NAFLD patients For example sensitivity specificity APRI 562 836 FibroScan M Probe 782 908 MRE 866 934 Child-Pugh classification and model for end-stage liver disease MELD scores are used as measures for assessment of degree of severity of liver disease These models have some drawbacks Ascites and encephalopathy included in Child-Pugh classification are subjective and may be variable according to the physicians judgment and the use of diuretics and lactulose INR which appears in both methods does not sufficiently reflect coagulopathy and liver function and is also variable throughout different laboratories Both are not sensitive enough for short interval periods
One of the major complications of cirrhosis and chronic hepatitis is Hepatocellular carcinoma HCC Most guidelines recommend cirrhotic patients to undergo abdominal ultrasound every 6 much to detect HCC given the expected tumor growth rate in the target population Although widely use the combination of ultrasound US with Alpha fetoprotein AFP is not recommended for surveillance in patients with active liver inflammation as the 6-8 gain in the detection rate does not counterbalance the increase in false positive results Like in previous issues a specific cost effective marker is still needed
Adropin is a 76-amino-acids secreted peptide which is encoded by the Enho gene The exact physiological role of Adropin in the liver is unknown However high levels of Adropin are correlated with low incidence of Type 2 Diabetes Mellitus higher levels of HDL cholesterol lower body-mass index BMI LDL cholesterol Triglyceride levels and blood pressure
Obesity has been recognized long ago as a significant risk factor for developing cancer and is an independent risk factor for HCC in patients with alcoholic odds ratio 32 and cryptogenic odds ratio 111 cirrhosis Serum Adropin levels were decreased and negatively correlated with liver injury in non-alcoholic steatohepatitis NASH mice Knockout of Adropin significantly exacerbated hepatic steatosis inflammatory responses and fibrosis in mice Furthermore the treatment with Adropin bioactive peptides slowed NASH progression in mice
In search for a good diagnostic and prognostic marker in patients with liver disease Adropin should be further investigated in humans
In this Open-label single-center study 50 adults 18 male and female with any degree of chronic liver disease will undergo a single blood test for serum levels of Adropin Levels will be measured using ELISA technique The results will be compared with the Child Pugh and MELD scores liver enzymes lipid profile coagulation factors and fibroscan results based on the patients clinical data
The gold standard for evaluation and follow up of liver fibrosis and cirrhosis is liver biopsy Its a costly procedure with risks of severe complications with sampling error and problematic long term follow up Non-invasive tools are broadly used with good results but none of the commonly used methods is perfect In one meta-analysis different methods were compared for diagnosis of cirrhosis in Non-alcoholic fatty liver disease NAFLD patients For example sensitivity specificity APRI 562 836 FibroScan M Probe 782 908 MRE 866 934 Child-Pugh classification and model for end-stage liver disease MELD scores are used as measures for assessment of degree of severity of liver disease These models have some drawbacks Ascites and encephalopathy included in Child-Pugh classification are subjective and may be variable according to the physicians judgment and the use of diuretics and lactulose INR which appears in both methods does not sufficiently reflect coagulopathy and liver function and is also variable throughout different laboratories Both are not sensitive enough for short interval periods
One of the major complications of cirrhosis and chronic hepatitis is Hepatocellular carcinoma HCC Most guidelines recommend cirrhotic patients to undergo abdominal ultrasound every 6 much to detect HCC given the expected tumor growth rate in the target population Although widely use the combination of ultrasound US with Alpha fetoprotein AFP is not recommended for surveillance in patients with active liver inflammation as the 6-8 gain in the detection rate does not counterbalance the increase in false positive results Like in previous issues a specific cost effective marker is still needed
Adropin is a 76-amino-acids secreted peptide which is encoded by the Enho gene The exact physiological role of Adropin in the liver is unknown However high levels of Adropin are correlated with low incidence of Type 2 Diabetes Mellitus higher levels of HDL cholesterol lower body-mass index BMI LDL cholesterol Triglyceride levels and blood pressure
Obesity has been recognized long ago as a significant risk factor for developing cancer and is an independent risk factor for HCC in patients with alcoholic odds ratio 32 and cryptogenic odds ratio 111 cirrhosis Serum Adropin levels were decreased and negatively correlated with liver injury in non-alcoholic steatohepatitis NASH mice Knockout of Adropin significantly exacerbated hepatic steatosis inflammatory responses and fibrosis in mice Furthermore the treatment with Adropin bioactive peptides slowed NASH progression in mice
In search for a good diagnostic and prognostic marker in patients with liver disease Adropin should be further investigated in humans
In this Open-label single-center study 50 adults 18 male and female with any degree of chronic liver disease will undergo a single blood test for serum levels of Adropin Levels will be measured using ELISA technique The results will be compared with the Child Pugh and MELD scores liver enzymes lipid profile coagulation factors and fibroscan results based on the patients clinical data
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