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Completed

NCT Number: NCT00137254

Insulin on Post Burn Hypermetabolism

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

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Key information

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

IV insulin

Stable Isotopes

Drug

IV administration of stable isotopes

Indocyanine green

Drug

IV administration of ICG

Primary outcomes

  1. 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

    Time frame: 45 days

  2. To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients

    Time frame: 45 days

Sponsors and collaborators

Lead sponsor

United States Army Institute of Surgical Research

Fed

Collaborators

  • The University of Texas Medical Branch, Galveston

Registry information

Official study title

Effects of Insulin on Post Burn Hypermetabolism

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Aug 29, 2005
Registry last updated
Apr 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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