Status:
COMPLETED
Role of Exenatide in NASH-a Pilot Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
Eight adult patients with known type 2 DM(Diabetic) and biopsy-proven NAFLD were treated with 5-10 mcg subcutaneous exenatide for 28 weeks. Liver histology was assessed using the NAFLD Activity Score ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00650546
Start Date
August 1 2006
End Date
August 1 2010
Last Update
April 11 2017
Active Locations (3)
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1
Indiana University
Indianapolis, Indiana, United States, 46202
2
Kansas City VA Medical Center
Kansas City, Missouri, United States
3
Fort Sam Houston
San Antonio, Texas, United States