Assessment of the Correlation Between Serum Levels of Adropin and Degree of Severity of Chronic Liver Disease
Primary Purpose
Chronic Liver Disease and Cirrhosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood test for serum Adropin
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Liver Disease and Cirrhosis
Eligibility Criteria
Inclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult) Sexes Eligible for Study: All
- Diagnosis of chronic liver disease of any etiology.
- Females of childbearing potential must be non-pregnant
- No known history of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, primary hematopoietic disease, neoplasm, or any other clinically significant medical disorder other than liver disease and the metabolic syndrome in patients with NASH.
- Patients must satisfy a medical examiner about their fitness to participate in the study.
- Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
- 1. Patients with evidence of other serious infectious, autoimmune, hepatic, nephritic or systemic disease or compromised organ function except for the metabolic syndrome in patients with NASH.
2. Patients with any acute medical situation (e.g. acute infection) within 48 hours of blood tests.
Sites / Locations
- Hadassah medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
Child Pugh A
Child Pugh B
Child Pugh C
HCC
Healthy
Arm Description
Outcomes
Primary Outcome Measures
correlation between degree of severity of chronic liver disease and serum adropin levels.
correlation between degree of severity of chronic liver disease and serum adropin levels.
Secondary Outcome Measures
Full Information
NCT ID
NCT04660409
First Posted
November 24, 2020
Last Updated
December 8, 2020
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT04660409
Brief Title
Assessment of the Correlation Between Serum Levels of Adropin and Degree of Severity of Chronic Liver Disease
Official Title
Assessment of the Correlation Between Serum Levels of Adropin and Degree of Severity of Chronic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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. It's 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 (56.2% ;83.6%), FibroScan M Probe (78.2%; 90.8%), MRE (86.6%; 93.4%) . 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 physician's 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 3.2) and cryptogenic (odds ratio 11.1) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease and Cirrhosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Child Pugh A
Arm Type
Other
Arm Title
Child Pugh B
Arm Type
Other
Arm Title
Child Pugh C
Arm Type
Other
Arm Title
HCC
Arm Type
Other
Arm Title
Healthy
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test for serum Adropin
Intervention Description
Blood test for serum Adropin
Primary Outcome Measure Information:
Title
correlation between degree of severity of chronic liver disease and serum adropin levels.
Description
correlation between degree of severity of chronic liver disease and serum adropin levels.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult) Sexes Eligible for Study: All
Diagnosis of chronic liver disease of any etiology.
Females of childbearing potential must be non-pregnant
No known history of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, primary hematopoietic disease, neoplasm, or any other clinically significant medical disorder other than liver disease and the metabolic syndrome in patients with NASH.
Patients must satisfy a medical examiner about their fitness to participate in the study.
Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
- 1. Patients with evidence of other serious infectious, autoimmune, hepatic, nephritic or systemic disease or compromised organ function except for the metabolic syndrome in patients with NASH.
2. Patients with any acute medical situation (e.g. acute infection) within 48 hours of blood tests.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yotam Kolben
Phone
+972507866767
Email
yotamkol@hadassah.org.il
Facility Information:
Facility Name
Hadassah medical center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yotam Kolben
Phone
0507866767
Email
yotamkol@hadassah.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of the Correlation Between Serum Levels of Adropin and Degree of Severity of Chronic Liver Disease
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