![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
The University of Texas, Galveston Shriners Hospitals for Children |
---|---|
Information provided by: | The University of Texas, Galveston |
ClinicalTrials.gov Identifier: | NCT00732485 |
Major burn injury causes significant insulin resistance on glucose and protein metabolism that persists for up to 6 months after the acute injury
This project proposes to answer the following questions:
ameliorate burn related hyperglycemia and protein catabolism?
Condition | Intervention | Phase |
---|---|---|
Burn |
Drug: fenofibrate Drug: placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Role of Mitochondrial Oxidation on Insulin Resistance in Burn Patients Treated With Fenofibrate |
Estimated Enrollment: | 20 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Fenofibrate: Active Comparator |
Drug: fenofibrate
Fenofibrate, PO, 5 mg/kg/day from admission to 6 months post burn
|
Placebo: Placebo Comparator |
Drug: placebo
Placebo, sugar pill, from admission to 6 months post burn
|
The following specific hypotheses will be investigated:
Ages Eligible for Study: | 7 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David N Herndon, MD | 409-770-6733 | dherndon@utmb.edu |
United States, Texas | |
Shriners Hospital for Children | Recruiting |
Galveston, Texas, United States, 77550 | |
Principal Investigator: Asle Aarsland, MD |
Principal Investigator: | Asle Aarsland, MD, PhD | University of Texas Medical Branch, Galveston |
Responsible Party: | University of Texas Medical Branch (UTMB), Galveston ( Asle Aarsland, MD, PhD, Principal Investigator ) |
Study ID Numbers: | 07-389, SHC 08-GAL-006 |
Study First Received: | August 8, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00732485 History of Changes |
Health Authority: | United States: Institutional Review Board |
Burn injury Fenofibrate Insulin resistance Mitochondrial function Fat oxidation |
PPAR Protein Glucose Wound |
Antimetabolites Burns Hyperinsulinism Metabolic Diseases Antilipemic Agents Wounds and Injuries |
Disorders of Environmental Origin Insulin Resistance Glucose Metabolism Disorders Procetofen Metabolic Disorder Insulin |
Burns Antimetabolites Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Wounds and Injuries Disorders of Environmental Origin |
Procetofen Pharmacologic Actions Hyperinsulinism Therapeutic Uses Insulin Resistance Glucose Metabolism Disorders |