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

Sponsor
Seoul St. Mary's Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01406704
Collaborator
GlaxoSmithKline (Industry)
26
Enrollment
4
Arms
119
Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Dec 1, 2010
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Histological evaluation [24 weeks]

      NASH Histological scoring system

    Secondary Outcome Measures

    1. Biomechanical measurement [24 weeks]

      liver function test, insulin resistance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul St. Mary's Hospital
    • GlaxoSmithKline

    Investigators

    • Principal Investigator: Kun Ho Yoon, Seoul St. Mary's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01406704
    Other Study ID Numbers:
    • KCMC-04-14
    First Posted:
    Aug 1, 2011
    Last Update Posted:
    Aug 19, 2011
    Last Verified:
    Jan 1, 2004
    Additional relevant MeSH terms:
    Hepatitis
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Thioctic Acid
    Rosiglitazone

    Study Results

    No Results Posted as of Aug 19, 2011