Insulin on Post Burn Hypermetabolism

Burns Clinical Trial

Official title:

Effects of Insulin on Post Burn Hypermetabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137254
• Other study ID #: H-05-004
• Secondary ID: NIH RO-1 GM06312
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: April 10, 2012
• Start date: December 2005
• Est. completion date: August 2008

Study information

• Verified date: April 2012
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Insulin
IV insulin
• Stable Isotopes
IV administration of stable isotopes
• Indocyanine Green
IV administration of ICG

Locations

Country	Name	City	State
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research	The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients		45 days	No