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

NCT00677521 | Terminated Phase 2

• 1 other identifier: 1000011557
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Improvement of hepatic steatosis as measured by proton magnetic resonance spectroscopy

  12 weeks

Secondary Outcomes (1)

• Postprandial substrate metabolism reflected in the respiratory quotient (RQ) measured by indirect calorimetry

  12 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Acarbose

Interventions

Acarbose DRUG

50mg tablet by mouth daily for the first 2 weeks, then twice a day for the next 2 weeks, and then three times a day for the next 8 weeks for a total of 12 weeks.

1

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Paul B. Pencharz, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Scientist

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: January 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

CA (1)