Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH

August 18, 2011 updated by: Seoul St. Mary's Hospital

Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)

This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Duration: 24 week-intervention Study Group: Four arms

  • Control: no intervention
  • Rosiglitazone: rosiglitazone (8 mg/day)
  • alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)
  • Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)

Exclusion Criteria:

  • alcohol consumption > 20g/day
  • viral hepatitis B and C
  • autoimmune hepatitis
  • Wilson's disease
  • hemochromatosis
  • alpha-1 antitrypsin deficiency
  • breast-feeding or pregnant females
  • subjects planning to become pregnant
  • severe comorbid medical conditions (such as severe cardiac, pulmonary, renal or psychological problems)
  • those not consenting for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Rosiglitazone
Rosiglitazone (8 mg/day)
Drug: Rosiglitazone
Rosiglitazone (8 mg/day)
Other Names:
  • Avandia
Experimental: alpha-lipoic acid
alpha-lipoic acid (1800 mg/day)
Drug: alpha-lipoic acid
alpha-lipoic acid (1800 mg/day)
Other Names:
  • Thioctic acid
Experimental: Rosiglitazone/alpha-lipoic acid
combination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)
Drug: Rosiglitazone/alpha-lipoic acid
combination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day)
Other Names:
  • Avandia/Thioctic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological evaluation
Time Frame: 24 weeks
NASH Histological scoring system
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomechanical measurement
Time Frame: 24 weeks
liver function test, insulin resistance
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Kun Ho Yoon, Seoul st. mary's hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2010

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

August 1, 2011

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

January 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCMC-04-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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