Liver Disease, Alcoholic Clinical Trial
Official title:
Effects of SAMe in Patients With Alcoholic Liver Disease
| Verified date | May 2017 |
| Source | University of California, Davis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 94 |
| Est. completion date | September 2009 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California, Davis Medical Center | Sacramento | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Davis | Abbott, Joint Clinical Research Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of California, Los Angeles, University of Colorado, Denver |
United States,
Medici V, Peerson JM, Stabler SP, French SW, Gregory JF 3rd, Virata MC, Albanese A, Bowlus CL, Devaraj S, Panacek EA, Rahim N, Richards JR, Rossaro L, Halsted CH. Impaired homocysteine transsulfuration is an indicator of alcoholic liver disease. J Hepatol — View Citation
Medici V, Virata MC, Peerson JM, Stabler SP, French SW, Gregory JF 3rd, Albanese A, Bowlus CL, Devaraj S, Panacek EA, Richards JR, Halsted CH. S-adenosyl-L-methionine treatment for alcoholic liver disease: a double-blinded, randomized, placebo-controlled — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in Serum AST Levels | Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups. | Week 0 to week 24 | |
| Secondary | Changes in Serum SAM | We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline. | September 2005- June 2009 |