A Pilot Study of Acarbose as Treatment for Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD)
Recruitment status was Recruiting
Tracking Information | |||||
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First Received Date ICMJE | May 12, 2008 | ||||
Last Updated Date | May 12, 2008 | ||||
Start Date ICMJE | February 2008 | ||||
Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Improvement of hepatic steatosis as measured by proton magnetic resonance spectroscopy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Postprandial substrate metabolism reflected in the respiratory quotient (RQ) measured by indirect calorimetry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Pilot Study of Acarbose as Treatment for Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD) | ||||
Official Title ICMJE | A Pilot Study of Acarbose as Treatment for Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD) | ||||
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. |
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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 associated with the development and progression of NAFLD. Therefore, we hypothesized that the chronic administration of acarbose attenuates NAFLD by improving glucose handling. This would be reflected in a reduction of intrahepatic fat accumulation. Proton Magnetic Resonance Spectroscopy is a sensitive and non-invasive method to measure changes in intrahepatic fat content. The primary endpoint of this study would be to demonstrate a reduction of intrahepatic fat as measured with Proton Magnetic Resonance Spectroscopy after 12 weeks administration of oral acarbose. Other relevant secondary outcomes that have been previously demonstrated to be associated with improvement of NAFLD included improvement of insulin resistance, normalizing of serum adiponectin, and a lowering of serum Leptin. A second intent of the study is to test 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. The consequence of insulin resistance is a relative inhibition of fatty oxidation. However, the chronic administration of acarbose improves insulin resistance and dampens the post-prandial surge in serum glucose and insulin. These changes in glucose handling could possibly result in a shift towards a pattern of preferential lipid oxidation. We anticipate either a lowering or blunting of the postprandial RQ after chronic administration of acarbose for 3 months. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Non-Alcoholic Fatty Liver Disease | ||||
Intervention ICMJE | Drug: Acarbose
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. |
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Study Arm (s) | Experimental: 1
Intervention: Drug: Acarbose |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 12 | ||||
Estimated Completion Date | July 2009 | ||||
Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 10 Years to 18 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00677521 | ||||
Other Study ID Numbers ICMJE | 1000011557 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Paul Pencharz/Principal Investigator, The Hospital for Sick Children | ||||
Study Sponsor ICMJE | The Hospital for Sick Children | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | The Hospital for Sick Children | ||||
Verification Date | May 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |