Clinical trial NCT00137254: Insulin on Post Burn Hypermetabolism
Official title: Effects of Insulin on Post Burn Hypermetabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Severe burns
Hyperinsulinemia
Insulin
Muscle protein kinetics
Immune function
Exercise
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
Collaborators: name: The University of Texas Medical Branch, Galveston
First posted: 2005-08-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 45 days
measure: To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: US Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: US Army Institute of Surgical Research
name: Steven E Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.