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Insulin on Post Burn Hypermetabolism

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin
Stable Isotopes
Indocyanine Green
Sponsored by
United States Army Institute of Surgical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Severe burns, Hyperinsulinemia, Insulin, Muscle protein kinetics, Immune function, Exercise

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • US Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 25, 2005
Last Updated
April 10, 2012
Sponsor
United States Army Institute of Surgical Research
Collaborators
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT00137254
Brief Title
Insulin on Post Burn Hypermetabolism
Official Title
Effects of Insulin on Post Burn Hypermetabolism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Institute of Surgical Research
Collaborators
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Severe burns, Hyperinsulinemia, Insulin, Muscle protein kinetics, Immune function, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
IV insulin
Intervention Type
Drug
Intervention Name(s)
Stable Isotopes
Intervention Description
IV administration of stable isotopes
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Intervention Description
IV administration of ICG
Primary Outcome Measure Information:
Title
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
Title
To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven E Wolf, MD
Organizational Affiliation
US Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9923795
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.
Results Reference
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Insulin on Post Burn Hypermetabolism

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