Insulin on Post Burn Hypermetabolism

Not Applicable

Completed

• Conditions: Burns
• Interventions: Drug: Insulin; Drug: Stable Isotopes; Drug: Indocyanine Green

• Registration Number: NCT00137254
• Lead Sponsor: United States Army Institute of Surgical Research

Brief Summary

The purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns.

Detailed Description

Severe injuries produce profound hypermetabolic stress responses which cause severe loss of lean body mass and muscle wasting, immunologic compromise, slowed wound healing, and related bone loss, all which contribute to increased morbidity, mortality, and prolonged recovery from injury. The results of hypermetabolism persist for weeks to months depending on the severity of the insult. Massive burns can cause severe catabolism and are an excellent model to study the general effects of injury on protein metabolism. Severe burns are characterized by dramatic increases in energy utilization and alterations in the metabolism of carbohydrates, fat, and protein.

Insulin treatment improves net protein synthesis in the severely burned, principally through improved muscle protein synthesis. Although controversy exist as to whether insulin is effective as an anabolic hormone through increasing protein synthesis or decreasing protein breakdown, we believe that consideration of the methods and experimental protocols used in the various studies bear consideration when evaluating this topic.

Study Timeline

• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Study Start: 2005-12
• Primary Completion: 2007-02
• Study Completion: 2008-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Burn equal to or greater than 20% total body surface area (TBSA)
• Between the ages of 18-72 years
• Burns occurred within 14 days of coming to burn center

Exclusion Criteria

• Heart attack within 3 months
• Have or have had cancer
• Seizure disorder
• Pregnancy
• Pre-existing arterial insufficiency
• Diabetes or known history of hypoglycemia
• Allergy to iodine or shellfish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Stable Isotopes	-
A	Insulin	-
A	Indocyanine Green	-

Primary Outcome Measures

Name	Time	Method
To determine the effect of euglycemic hyperinsulinemia throughout the hospital course on net muscle protein synthesis, and to relate continued muscle anabolism to improved lean body mass and improved functional recovery in severely burned patients	45 days
To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients	45 days

Trial Locations

Locations (1)

US Army Institute of Surgical Research; 🇺🇸 Fort Sam Houston, Texas, United States