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Mitochondrial Oxidation and Insulin Resistance in Burn Patients Treated With Fenofibrate

NCT00732485 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2012-12-11

No results posted yet for this study

Summary

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:

1. Will fenofibrate given to burn patients with insulin resistance restore their insulin sensitivity?
2. What is the relationship between mitochondrial dysfunction in muscle tissue as the causative mechanism of burn related insulin resistance?
3. To what extent will the restored insulin sensitivity affect glucose and protein metabolism in muscle, regenerating wounds and the liver, i.e. ameliorate burn related hyperglycemia and protein catabolism?

Conditions

  • Burn

Interventions

DRUG

fenofibrate

Fenofibrate, PO, 5 mg/kg/day from admission to 6 months post burn

DRUG

placebo

Placebo, sugar pill, from admission to 6 months post burn

Sponsors & Collaborators

  • Shriners Hospitals for Children

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • David Herndon, MD · University of Texas Medical Branch, Galveston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-12-31
Completion
2013-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00732485 on ClinicalTrials.gov