Status:
TERMINATED
A Pilot Study of Acarbose as Treatment for Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
10-18 years
Phase:
PHASE2
Brief Summary
The objective of this study is to demonstrate a reduction of intrahepatic fat as measured with Proton Magnetic Resonance Spectroscopy after 12 weeks administration of oral acarbose. The study will als...
Detailed Description
The chronic administration of acarbose has been shown to improve insulin resistance and reverse impaired glucose tolerance. Both these conditions, especially insulin resistance, are physiologically as...
Eligibility Criteria
Inclusion
- Age:10-18 years old
- Liver biopsy proven NAFLD. NAFLD defined histologically as greater than 5% hepatic macrovesicular steatosis with any degree of chronic inflammation and hepatic fibrosis; clinical definition requires that other liver diseases associated with fatty liver be excluded.
- Insulin resistance with HOMA-IR score \>3.0
- Hepatic steatosis \>5% wet weight on hepatic proton magnetic resonance spectroscopy (1H-MRS)
- INR \<1.2; Conjugated Bilirubin \<2umol/L and Albumin \>35gm/L
Exclusion
- Type 1 or 2 diabetes mellitus
- Treatment with oral hypoglycemic agents
- Ongoing participation in a formal weight loss program or interventional clinical trial
- Panhypopituitarism and genetic causes of obesity i.e. Prader-Willi syndrome
- Alcohol consumption \>20 g/day
- Serum creatinine above normal range for age
- History of previous or predisposition to intestinal obstruction
- Pre-existing gastrointestinal disease i.e. inflammatory bowel disease; celiac disease
- Drugs that influence energy metabolism, intestinal transit, substrate metabolism
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00677521
Start Date
January 1 2007
End Date
August 1 2008
Last Update
August 19 2013
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada