A Pilot Study of Acarbose as Treatment for Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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 also examine the hypothesis of whether the chronic administration of acarbose in patients with NAFLD will influence postprandial substrate metabolism reflected in the RQ measured by indirect calorimetry.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Acarbose

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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