Recruiting
Phase 2

Rosiglitazone vs. Metformin, Avandia

Sponsor:

Brooke Army Medical Center

Code:

NCT00699036

Conditions

Nonalcoholic Steatohepatitis

Nonalcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

avandia

metformin

losartan

Study Details

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?

Conditions

Nonalcoholic Steatohepatitis

Nonalcoholic Fatty Liver Disease

Study ID

NCT00699036

Start date

Apr, 2007

Status verified date

Jun, 2009

Completion date

Aug, 2009

Anticipated

Primary completion date

Jul, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

avandia

experimental: 2

avandia plus metformin

experimental: 3

avandia plus losartan

Interventions

avandia

4 mg twice daily

metformin

500 mg twice daily for 48 weeks

losartan

losartan 50 mg once daily

Primary outcome measure

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

Central Contacts and Locations

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Dawn M Torres, MD

210-916-5649

Principal Investigator:

Dawn M Torres, MD

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Jun 19, 2009

Last verified

Jun, 2009

Keywords

  • nonalcoholic steatohepatitis (NASH)
  • fatty liver
  • insulin resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2009-06-19.