Overview

Effects of SAMe in Patients With Alcoholic Liver Disease

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
Summary
Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. The hypothesis of the clinical study was that provision of the methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics without liver disease, and normal healthy subjects, and b) to determine the treatment effects of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical features of liver injury in ALD patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of California, Davis
Collaborators:
Abbott
Joint Clinical Research Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of California, Los Angeles
University of Colorado, Denver
Criteria
Inclusion Criteria

- ALD) a history of chronic alcoholism according to established AUDIT and WHO criteria
with the presence of clinical and laboratory features of established liver disease.
Also, willingness to undergo liver biopsies at start and completion of the study, and
to comply with study medication or placebo and required clinic visits and blood
sampling.

- a history of chronic alcoholism without evidence of liver disease;

- healthy subjects without history of alcoholism or presence of liver disease.

Exclusion Criteria:

- viral Hepatitis B or C

- hemochromatosis

- Wilson Disease

- sclerosing cholangitis

- primary biliary cirrhosis

- other chronic disease

- renal insufficiency