Treating Nonalcoholic Steatohepatitis With Pioglitazone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jay Hoofnagle, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00062764
First received: June 12, 2003
Last updated: December 14, 2012
Last verified: December 2012
Results First Received: March 1, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis
Intervention: Drug: Actos (Pioglitazone)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between March 2001 and April 2002, 25 patients suspected of having NASH were evaluated, and 18 were enrolled in the study after screening.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pioglitazone Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.

Participant Flow:   Overall Study
    Pioglitazone  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pioglitazone Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.

Baseline Measures
    Pioglitazone  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 11  
Gender  
[units: participants]
 
Female     11  
Male     7  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic     3  
White     13  
Mixed     2  
Region of Enrollment  
[units: participants]
 
United States     18  
Obesity Distribution  
[units: participants]
 
BMI>30     11  
BMI<=30     7  
2-hr glucose diabetes mellitus  
[units: participants]
 
>200 mg/dL     2  
<=200 mg/dL     16  
2-hr glucose (Impaired glucose tolerance)  
[units: participants]
 
140-199 mg/dL     11  
other     7  
Metabolic syndrome  
[units: participants]
 
Yes     7  
No     11  
Fasting glucose  
[units: participant]
 
110-125 mg/dL     2  
other     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Improvement in Liver Histology   [ Time Frame: 48 weeks ]

2.  Secondary:   Number of Patients With Impaired Glucose Tolerance After Treatment   [ Time Frame: 48 weeks ]

3.  Secondary:   Mean Increase of Insulin Sensitivity Index   [ Time Frame: 48 weeks ]

4.  Secondary:   Average Increase in Weight After Treatment   [ Time Frame: 48 weeks ]

5.  Secondary:   Mean BMI Change   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

A major limitation of this study was the lack of a concurrently followed control group.

Another important shortcoming of this study was that patients were treated for 48 weeks only.

 


Results Point of Contact:  
Name/Title: Jay H. Hoofnagle, MD
Organization: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
phone: 3014961333
e-mail: hoofnaglej@extra.niddk.nih.gov


Publications:

Responsible Party: Jay Hoofnagle, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00062764     History of Changes
Other Study ID Numbers: 030212, 03-DK-0212
Study First Received: June 12, 2003
Results First Received: March 1, 2011
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration