Comparison of ALD, NASH, and Healthy Control Patients

Launched by THE CLEVELAND CLINIC · Jul 19, 2017

Keywords

ClinConnect Summary

This clinical trial is studying different stages of Alcoholic Liver Disease (ALD) and comparing them with healthy individuals and heavy drinkers who do not have liver disease. The goal is to collect biological samples, like blood and urine, from people with various degrees of liver damage due to alcohol, as well as from healthy controls. These samples will help researchers understand what specific markers in the body might indicate how severe the disease is and how well patients might respond to treatments.

To participate in this trial, individuals must meet certain criteria. Eligible participants include those with different stages of ALD, such as those with fat accumulation in the liver, mild to advanced liver inflammation, or cirrhosis. Healthy controls must have low scores on a drinking questionnaire, indicating they do not have alcohol use issues. Participants can expect to provide samples and contribute to important research that may lead to better understanding and treatment of liver diseases related to alcohol. It's important to note that individuals with certain health conditions, like cancer or severe obesity, may not be eligible.

Gender

ALL

Eligibility criteria

• • Alcoholic Steatosis Patients
• • Inclusion
• • Fat accumulation (Steatosis) without signs of fibrosis/ inflammation in patients with alcohol abuse (alcohol intake \>60 g/day in men and \>40 g/day in women)
• • Abnormal liver serum tests indicative of liver disease (elevated AST\>ALT, y-glutamyl transpeptidase and bilirubin) .
• • Alcoholic Hepatitis with Mild Fibrosis
• • Inclusion
• • Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
• • Polymorphonuclear infiltrate
• • Fibrosis stage 1-2
• • Alcoholic Hepatitis with Advanced Fibrosis
• • Inclusion
• • Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
• • Polymorphonuclear infiltrate
• • Fibrosis stage 3-4.
• • Alcoholic Cirrhosis
• • Inclusion
• • Fibrosis stage 4
• • Presence of complications of cirrhosis such as esophageal varices with our without a previous episode of bleeding, splenomegaly, ascites, hepatic corroborate the diagnosis of cirrhosis.
• • Alcoholic Cirrhosis with HCC
• • Inclusion
• • -Diagnostic criteria of cirrhosis and established HCC. The diagnosis of HCC will be established based on histological confirmation or contrast-enhanced radiographic imaging according to the AASLD recommendations.
• • Exclusion
• • BMI\>35
• • HBV
• • Hemochromatosis
• • Wilson's disease
• • Autoimmune hepatitis
• • Drug-inducted liver disease
• • Hepatitis C
• • Antitrypsin deficiency
• • Patients who do not sign informed consent.
• • Non-alcoholic steatohepatitis
• • Inclusion -Biopsy proven NASH and chronic liver disease due to HCV patients.
• • Exclusion
• • Cancer
• • Diabetes
• • Hypertension
• • CAD or stroke
• • Past history of liver disease
• • Hepatitis C
• • Antitrypsin deficiency
• • Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men
• • BMI \>35.
• • Healthy controls
• • Inclusion
• • -AUDIT-C score less than 4 in men and less than 3 in women.
• • Exclusion
• • Cancer (except of non-melanoma skin cancer)
• • Diabetes
• • Hypertension
• • Hypercholesterolemia
• • Coronary artery disease or stroke
• • History of current or past liver disease of any etiology
• • BMI \>27Kg/m2