Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

This study is currently recruiting participants.

Verified by Brooke Army Medical Center, June 2009

First Received: June 16, 2008 Last Updated: June 18, 2009 History of Changes

Sponsor:	Brooke Army Medical Center
Information provided by:	Brooke Army Medical Center
ClinicalTrials.gov Identifier:	NCT00699036

Purpose

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?

Condition	Intervention	Phase
Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease	Drug: avandia Drug: metformin Drug: losartan	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

Drug Information available for: Losartan Rosiglitazone Losartan potassium Rosiglitazone Maleate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:

liver biopsy histologic improvement [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

serum transaminases [ Time Frame: throughout study (ongoing) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	165
Study Start Date:	April 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental avandia	Drug: avandia 4 mg twice daily
2: Experimental avandia plus metformin	Drug: avandia 4 mg twice daily Drug: metformin 500 mg twice daily for 48 weeks
3: Experimental avandia plus losartan	Drug: avandia 4 mg twice daily Drug: losartan losartan 50 mg once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients between 18-70 years old
Negative urine pregnancy test in females
History of elevated liver associated enzymes (ALT > 40)
Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH

Exclusion Criteria:

ALT greater than three times normal
NYHA class 3 or 4 heart failure
Any congestive heart failure patient on insulin
Patients on one of the 3 study drugs within the past 3 months prior to enrollment
Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male
Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
Serum creatinine on initial screening of greater than 1.4
Known hypersensitivity to rosiglitazone, metformin, or losartan
Known history of diabetic ketoacidosis
Female that is breastfeeding
Insulin dependent diabetic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699036

Locations

United States, Texas
Brooke Army Medical Center	Recruiting
San Antonio, Texas, United States, 78234
Contact: Dawn M Torres, MD 210-916-5649
Principal Investigator: Dawn M Torres, MD
Sub-Investigator: Stephen A Harrison, MD

Sponsors and Collaborators

Brooke Army Medical Center

Investigators

Principal Investigator:

Dawn M Torres, MD

Brooke Army Medical Center

More Information

No publications provided

Responsible Party:	Brooke Army Medical Center ( Dawn M. Torres, MD. Principal Investigator )
Study ID Numbers:	C.2007.066
Study First Received:	June 16, 2008
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00699036 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Brooke Army Medical Center:

nonalcoholic steatohepatitis (NASH)
fatty liver
insulin resistance

Additional relevant MeSH terms:

Liver Diseases
Losartan
Molecular Mechanisms of Pharmacological Action
Metformin
Physiological Effects of Drugs
Fatty Liver
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Digestive System Diseases
Hypoglycemic Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Rosiglitazone

ClinicalTrials.gov processed this record on February 08, 2010