Mitochondrial Oxidation and Insulin Resistance in Burn Patients Treated With Fenofibrate

NCT00732485 | Withdrawn Phase 2 DMC

• 2 other identifiers: 07-389SHC 08-GAL-006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Will fenofibrate given to burn patients with insulin resistance restore their insulin sensitivity?
2. 2.What is the relationship between mitochondrial dysfunction in muscle tissue as the causative mechanism of burn related insulin resistance?
3. 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

Keywords

Burn injury; Fenofibrate; Insulin resistance; Mitochondrial function; Fat oxidation; PPAR; Protein; Glucose; Wound

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity on glucose and protein metabolism

  From admission to burn unit to 6 months post burn

Secondary Outcomes (3)

• Systemic glucose homeostasis

  Admission to 6 months post burn

• Muscle protein balance

  Admission to 6 months post burn

• Wound protein balance

  Admission to 6 months post burn

Study Arms (2)

Fenofibrate

ACTIVE COMPARATOR

Drug: fenofibrate

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

fenofibrate DRUG

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

Fenofibrate

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 7 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients \> 7 years old with burns covering 40% or more of body surface who are admitted to the Shriners Hospital for Children, Galveston, Texas

You may not qualify if:

• Abnormal liver and kidney function,
• Pregnancy,
• Diabetes mellitus,

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Shriners Hospitals for Children: collaborator

Related Publications (1)

• Cree MG, Zwetsloot JJ, Herndon DN, Qian T, Morio B, Fram R, Sanford AP, Aarsland A, Wolfe RR. Insulin sensitivity and mitochondrial function are improved in children with burn injury during a randomized controlled trial of fenofibrate. Ann Surg. 2007 Feb;245(2):214-21. doi: 10.1097/01.sla.0000250409.51289.ca.

  PMID: 17245174 RESULT

MeSH Terms

Conditions

Burns; Insulin Resistance; Wounds and Injuries

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• David Herndon, MD

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: December 11, 2012

Record last verified: 2012-12