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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Brooke Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00699036
First received: June 16, 2008
Last updated: June 18, 2009
Last verified: June 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Brooke Army Medical Center:
nonalcoholic steatohepatitis (NASH)
fatty liver
insulin resistance

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Losartan
Metformin
Rosiglitazone
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014