Insulin on Post Burn Hypermetabolism

United States Army Institute of Surgical Research

Status: Completed

Conditions: Burns

Treatments: Drug: Insulin; Drug: Indocyanine Green; Drug: Stable Isotopes

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00137254

NIH RO-1 GM063120-02

H-05-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

A

Active Comparator group

Treatment:

Drug: Indocyanine Green

Drug: Stable Isotopes

Drug: Insulin