Status:
COMPLETED
Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
National Institutes of Health (NIH)
Takeda Pharmaceuticals North America, Inc.
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
21-70 years
Phase:
PHASE4
Brief Summary
To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).
Detailed Description
v. 4/1/2003 Role of Pioglitazone in the Treatment of Nonalcoholic Steatohepatitis 1\. PURPOSE/SPECIFIC AIMS To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NAS...
Eligibility Criteria
Inclusion
- Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
- Patients must have an age range between 21 to 70 years (inclusive).
- NASH confirmed by liver biopsy.
- Subjects must meet the criteria for impaired glucose tolerance (FPG concentration \<126 mg/dl and a two hour plasma glucose value during the oral glucose tolerance test \[OGTT\] ≥140 but \<200 mg/dl) or type 2 diabetes mellitus (FPG concentration ≥ 126 mg/dl or a two hour plasma glucose value during the OGTT ≥200 mg/dl) (62). Subjects with a FPG greater than 260 mg/dl will be excluded from the study.
- Diabetic patients will be allowed to be on sulfonylureas or repaglinide but not on metformin, a thiazolidinedione or insulin. Patients must have been on a stable dose of allowed chronic medications for four weeks prior to entering the double-blind treatment period.
- Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate mechanical contraceptive precautions (i.e. intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period. Patients on oral contraceptives or an hormonal implant will be excluded.
- All participants must have the following laboratory values:
- Hemoglobin ≥ 13 gm/dl in males, or
- ≥ 12 gm/dl in females WBC count ≥ 3,000/mm3 Neutrophil count ≥ 1,500/mm3 Platelets ≥ 100,000/mm3 Prothrombin time within 3 seconds of control Albumin ≥3.0 g/dl Serum creatinine ≤ 1.6 mg/dl Creatinine phosphokinase ≤ 2 times upper limit of normal AST (SGOT) ≤ 2.5 times upper limit of normal ALT (SGPT) ≤ 2.5 times upper limit of normal Alkaline phosphatase ≤ 2.5 times upper limit of normal
Exclusion
- Any cause of chronic liver disease other than NASH (such as -but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency).
- Any clinical evidence or history of ascitis, bleeding varices, or spontaneous encephalopathy.
- No past (for at least for 1 year) or current history of alcohol abuse (alcohol consumption greater than one drink per day).
- Prior surgical procedures to include gastroplasty, jejuno-ileal or jejunocolic bypass.
- Prior exposure to organic solvents such as carbon tetrachloride.
- Total parenteral nutrition (TPN) within the past 6 months.
- Diabetics with a FPG greater than 260 mg/dl on initial visit.
- Diabetics who are taking metformin, a thiazolidinedione or insulin.
- Subjects with type 1 diabetes mellitus.
- Patients on chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for 4 weeks before entry into the study. Patients on estrogens or other hormonal replacement therapy, tamoxifen, raloxifene, oral glucocorticoids or chloroquine will be excluded.
- Patients with a history of clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation), will not be studied.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00227110
Start Date
October 1 2002
End Date
January 1 2006
Last Update
October 14 2009
Active Locations (1)
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1
Audie L Murphy VA Hospital
San Antonio, Texas, United States, 78229