Insulin on Post Burn Hypermetabolism

This study has been completed.
Sponsor:
Collaborator:
The University of Texas, Galveston
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00137254
First received: August 25, 2005
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Burns
Drug: Insulin
Drug: Stable Isotopes
Drug: Indocyanine Green

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Insulin on Post Burn Hypermetabolism

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: December 2005
Study Completion Date: August 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Insulin
IV insulin
Drug: Stable Isotopes
IV administration of stable isotopes
Drug: Indocyanine Green
IV administration of ICG

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

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137254

Locations
United States, Texas
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
The University of Texas, Galveston
Investigators
Principal Investigator: Steven E Wolf, MD US Army Institute of Surgical Research
  More Information

Publications:
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00137254     History of Changes
Other Study ID Numbers: H-05-004, NIH RO-1 GM063120-02
Study First Received: August 25, 2005
Last Updated: April 10, 2012
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
Severe burns
Hyperinsulinemia
Insulin
Muscle protein kinetics
Immune function
Exercise

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014