Insulin on Post Burn Hypermetabolism

NCT ID: NCT00137254

Last Updated: 2012-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-08-31

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

IV insulin

Stable Isotopes

Intervention Type: DRUG

IV administration of stable isotopes

Indocyanine Green

Intervention Type: DRUG

IV administration of ICG

Interventions

Insulin

IV insulin

Intervention Type: DRUG

Stable Isotopes

IV administration of stable isotopes

Intervention Type: DRUG

Indocyanine Green

IV administration of ICG

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: collaborator

United States Army Institute of Surgical Research

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven E Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

US Army Institute of Surgical Research

Locations

US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Countries

United States

References

Ferrando AA, Chinkes DL, Wolf SE, Matin S, Herndon DN, Wolfe RR. A submaximal dose of insulin promotes net skeletal muscle protein synthesis in patients with severe burns. Ann Surg. 1999 Jan;229(1):11-8. doi: 10.1097/00000658-199901000-00002.

Reference Type: BACKGROUND

PMID: 9923795 (View on PubMed)

Other Identifiers

NIH RO-1 GM063120-02

Identifier Type: -

Identifier Source: secondary_id

H-05-004

Identifier Type: -

Identifier Source: org_study_id