Insulin on Post Burn Hypermetabolism

NCT00137254 | Completed

• 2 other identifiers: H-05-004NIH RO-1 GM063120-02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Burns

Keywords

Severe burns; Hyperinsulinemia; Insulin; Muscle protein kinetics; Immune function; Exercise

Outcome Measures

Primary Outcomes (2)

• 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

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

  45 days

Study Arms (1)

A

ACTIVE COMPARATOR

Drug: Insulin; Drug: Stable Isotopes; Drug: Indocyanine Green

Interventions

Insulin DRUG

IV insulin

A

Stable Isotopes DRUG

IV administration of stable isotopes

A

Indocyanine Green DRUG

IV administration of ICG

A

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Institute of Surgical Research: lead
• The University of Texas Medical Branch, Galveston: collaborator

Study Sites (1)

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related 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. doi: 10.1097/00000658-199901000-00002.

  PMID: 9923795 BACKGROUND

MeSH Terms

Conditions

Burns; Hyperinsulinism; Insulin Resistance; Motor Activity

Interventions

Insulin; Indocyanine Green

Condition Hierarchy (Ancestors)

Wounds and Injuries; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Steven E Wolf, MD

  US Army Institute of Surgical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: December 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: August 1, 2008
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

US (1)