Hepatitis Clinical Trial
Official title:
Treatment of Nonalcoholic Steatohepatitis With Metformin
Nonalcoholic Steatohepatitis (NASH) is associated with progressive liver disease, fibrosis,
and cirrhosis. Although the cause of NASH is unknown, it is often associated with obesity,
type 2 diabetes, and insulin resistance. At present, there are no approved treatments for
NASH patients, but an experimental approach has focused on improving their insulin
sensitivity. Metformin is one of the most commonly used medications for the treatment of
diabetes.
The purpose of this study is to determine whether the medical problems of NASH patients,
specifically liver damage, improves when their insulin sensitivity is enhanced with
metformin.
The study will last 3 to 5 years and will enroll up to 30 patients. Participants will
undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will
then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same
dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will
increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year,
participants will undergo a repeat medical examination and liver biopsy.
Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from
simple fatty liver (steatosis) to steatosis with inflammation and necrosis to cirrhosis,
that occurs in persons who drink little or no alcohol. Nonalcoholic steatohepatitis (NASH)
represents the more severe end of this spectrum and is associated with progressive liver
disease, fibrosis and cirrhosis. The etiology of NASH is unclear, but it is often associated
with obesity, type 2 diabetes, hyperlipidemia and insulin resistance. We have recently
conducted a study of a 48-week course of pioglitazone in 21 non-diabetic patients with NASH.
Serum aminotransferase levels and liver histology improved in most patients and the
improvements correlated with changes in insulin sensitivity. These results are promising,
but pioglitazone is associated with significant weight gain, is quite expensive, and its
long-term safety is yet to be proven. In contrast, metformin is inexpensive, extremely well
tolerated, and of proven long-term safety in patients with diabetes and pre-diabetes.
In this study, we propose to treat 20 non-diabetic patients with NASH with metformin for
48-weeks. After an initial evaluation for insulin sensitivity, fat distribution and liver
biopsy, patients will receive gradually increasing doses of metformin orally to a maximum of
2000 mg daily. Patients will be monitored at regular intervals for symptoms of liver
disease, side effects of metformin and serum biochemical and metabolic indices. At the end
of 48-weeks, patients will have a repeat medical evaluation and liver biopsy. Pre and post
treatment liver histology, fat distribution and insulin sensitivity will be compared. The
primary end point of successful therapy will be improvement in hepatic histology as
determined by reduction of at least three points in NASH activity score. Secondary end
points will be improvement in insulin sensitivity, body fat distribution, and liver
biochemistry.
;
Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05989958 -
The Safety and Tolerability Study of HepaCure in Chinese Subjects With Acute-On-Chronic Liver Failure
|
Phase 1 | |
Not yet recruiting |
NCT06395129 -
Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
|
||
Terminated |
NCT01443923 -
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
|
Phase 4 | |
Completed |
NCT00679692 -
Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease
|
N/A | |
Completed |
NCT00300209 -
Manhattan HIV/Hepatology Brain Bank
|
N/A | |
Recruiting |
NCT05563961 -
A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and SafeTynadol® in Healthy Volunteers
|
N/A | |
Recruiting |
NCT05635266 -
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
|
||
Completed |
NCT00160407 -
Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 4 | |
Recruiting |
NCT03692897 -
An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
|
||
Completed |
NCT03509688 -
The Curative Effect of Entecavir Combined Resveratrol on HBV patients-a Multi-center, Random, Open Clinical Trial
|
N/A | |
Recruiting |
NCT02275195 -
Immune Cell Dysfunction in Severe Alcoholic Hepatitis
|
||
Completed |
NCT01740089 -
Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C
|
Phase 2/Phase 3 | |
Completed |
NCT00987337 -
Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
|
Phase 2 | |
Completed |
NCT00929786 -
Anti-tuberculosis (TB) Drug Levels and Hepatotoxicity
|
N/A | |
Completed |
NCT00564642 -
Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity
|
N/A | |
Completed |
NCT00080236 -
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
|
Phase 2 | |
Recruiting |
NCT05719480 -
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Liver Cancer
|
||
Suspended |
NCT04306939 -
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
|
||
Completed |
NCT03482388 -
Crowdsourcing to Promote HBV and HCV Testing in China
|
N/A |