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Role of Exenatide in NASH-a Pilot Study (NAFLD)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00650546
First received: March 28, 2008
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.


Condition Intervention Phase
Nonalcoholic Fatty Liver Disease
(NAFLD)
 Drug: Exenatide
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Exenatide in Treatment of NASH-a Pilot Study

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Improvement in hepatic histology after 24 weeks of treatment as determined by liver biopsies pre and post-treatment [ Time Frame: 24-28 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in anthropometric measures such as weight, BMI, WHR [ Time Frame: 24-28 weeks ] [ Designated as safety issue: Yes ]
  • Change in NAS from baseline to post-treatment [ Time Frame: 24-28 weeks ] [ Designated as safety issue: Yes ]
  • Changes in fibrosis, steatosis, lobular inflammation, cellular ballooning and other specific changes from the histologic scoring from baseline to post-treatment [ Time Frame: 24-28 weeks ] [ Designated as safety issue: Yes ]
  • Changes in serum aminotransferase levels [ Time Frame: 24-28 weeks ] [ Designated as safety issue: Yes ]
  • Changes in selected cytokines and adipokine levels [ Time Frame: 24-28 weeks ] [ Designated as safety issue: Yes ]
  • Changes in insulin resistance as measure by HOMA-IR [ Time Frame: 24-28 weeks ] [ Designated as safety issue: Yes ]
  • Changes in systemic lipid peroxidation and malondialdehyde [ Time Frame: 24-28 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: August 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated
 Drug: Exenatide
5 mcg twice a day titrated to 10 mcg twice a day
Other Name: Byetta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Well documented NASH based on clinical and histological criteria. Liver biopsy must have been obtained within 12-months prior to initiation of the study.
  • Subjects must have known diabetes (either diet controlled or only on Metformin or sulfonylureas such as glyburide or glipizide).
  • Subjects must be 18 year or older.

Exclusion Criteria:

  • Co-existing etiologies for chronic liver disease (hepatitis B or C, autoimmune or hemochromatosis, etc.).
  • Clinical or histological evidence of cirrhosis.
  • Alanine aminotransferase or aspartate aminotransferase > 300 IU/L.
  • Uncontrolled diabetes (hemoglobin A1C greater than or equal to 9%).
  • Insulin or TZD dependant DM.
  • Known human immunodeficiency virus infection.
  • Current or history of significant alcohol consumption within past 5 years. Significant alcohol consumption is defined as >20 grm/day in females and >30 grms/day in males or if alcohol consumption cannot satisfactorily be quantified.
  • Serum creatinine of greater than or equal to 2 mg/dl.
  • Active, serious medical disease (cardiac, renal, pulmonary, dermatologic, psychiatric illness) with likely life expectancy less 5 years.
  • Current or previous malignancy with expected life expectancy less than 5-years (other than basal cell cancer of the skin).
  • Use of drugs historically associated with NASH.
  • Histological evidence of malignancy, 4+ iron deposition, or any other type of liver disease.
  • Active substance abuse, such as alcohol,inhaled or injection drugs with the previous one year.
  • Known intolerance or allergy to exenatide (Byetta).
  • History of neuroglycopenia.
  • Women of childbearing potential must have had a negative pregnancy test prior to starting the study and should be willing to avoid pregnancy during the study period.
  • Women must not be nursing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650546

Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States
United States, Texas
Fort Sam Houston
San Antonio, Texas, United States
Sponsors and Collaborators
Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Naga Chalasani, MD Indiana University School of Medicine
  More Information

Additional Information:
Letter to the Editor, doi:10.1038 / ajg.2010.363, American Journal of Gastroenterology  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00650546     History of Changes
Other Study ID Numbers: DK61737, U01DK061737
Study First Received: March 28, 2008
Last Updated: May 9, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Indiana University:
Non-alcoholic steatohepatitis
NASH

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013