Treating Nonalcoholic Steatohepatitis With Pioglitazone

This study has been completed.

Study NCT00062764 Information provided by National Institutes of Health Clinical Center (CC)

First Received on June 12, 2003. Last Updated on March 1, 2011 History of Changes

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
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Reporting Groups

	Description
Group 1	No text entered.

Participant Flow: Overall Study

	Group 1
STARTED	18
COMPLETED	18
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Group 1	No text entered.

Baseline Measures

	Group 1
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
Patients with overweight, BMI 25-29 [units: participants]	7
Obese patients, BMI>30 [units: participants]	11
Impaired fasting glucose, 110-125 mg/dL [units: participants]	2
2-hr glucose DM (>200 mg/dL) [units: participants]	2
2-hr glucose IGT (140-199 mg/dL) [units: participants]	11
Metabolic syndrome [units: participants]	7

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

Mean BMI Change [ Time Frame: 48 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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.

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:

Byron D, Minuk GY. Clinical hepatology: profile of an urban, hospital-based practice. Hepatology. 1996 Oct;24(4):813-5.

Ludwig J, Viggiano TR, McGill DB, Oh BJ. Nonalcoholic steatohepatitis: Mayo Clinic experiences with a hitherto unnamed disease. Mayo Clin Proc. 1980 Jul;55(7):434-8.

Caldwell SH, Oelsner DH, Iezzoni JC, Hespenheide EE, Battle EH, Driscoll CJ. Cryptogenic cirrhosis: clinical characterization and risk factors for underlying disease. Hepatology. 1999 Mar;29(3):664-9.

Responsible Party:	Jay H. Hoofnagle, M.D./National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
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:	March 1, 2011
Health Authority:	United States: Federal Government