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

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ClinicalTrials.gov Identifier: NCT00699036

Recruitment Status : Unknown

Verified June 2009 by Brooke Army Medical Center.
Recruitment status was: Recruiting

First Posted : June 17, 2008

Last Update Posted : June 19, 2009

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Sponsor:

Information provided by:

Brooke Army Medical Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease	Drug: avandia Drug: metformin Drug: losartan	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	165 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	April 2007
Estimated Primary Completion Date :	July 2009
Estimated Study Completion Date :	August 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Non-alcoholic fatty liver disease

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

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 avandia	Drug: avandia 4 mg twice daily
Experimental: 2 avandia plus metformin	Drug: avandia 4 mg twice daily Drug: metformin 500 mg twice daily for 48 weeks
Experimental: 3 avandia plus losartan	Drug: avandia 4 mg twice daily Drug: losartan losartan 50 mg once daily

Outcome Measures

Primary Outcome Measures :

liver biopsy histologic improvement [ Time Frame: end of study ]

Secondary Outcome Measures :

serum transaminases [ Time Frame: throughout study (ongoing) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699036

Locations

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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

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Principal Investigator:	Dawn M Torres, MD	Brooke Army Medical Center

More Information

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Responsible Party:	Dawn M. Torres, MD. Principal Investigator, Brooke Army Medical Center
ClinicalTrials.gov Identifier:	NCT00699036
Other Study ID Numbers:	C.2007.066
First Posted:	June 17, 2008 Key Record Dates
Last Update Posted:	June 19, 2009
Last Verified:	June 2009

Keywords provided by Brooke Army Medical Center:


nonalcoholic steatohepatitis (NASH) fatty liver insulin resistance

Additional relevant MeSH terms:

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Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases Metformin Rosiglitazone Losartan	Hypoglycemic Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action

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