Glucose Control in Severely Burned Patients

Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential

The central aim of this application is to determine whether improved outcomes with tight euglycemic control are due to insulin-specific responses. The investigators hypothesize that improving insulin resistance will lead to decreased inflammatory and hypermetabolic responses, as well as restored glucose metabolism, and so result in improved clinical outcome of severely burned patients.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Drug: Metformin; Drug: Humulin R

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between 18 and 90 years of age
• >20% TBSA
• Admitted to the burn unit within 120 hours following burn
• At least 1 surgical intervention necessary

Exclusion Criteria:

• death upon admission
• decision not to treat due to burn injury severity
• presence of anoxic brain injury that is not expected to result in complete recovery
• known history of AIDS, ARC, HIV, Hepatitis B-E
• history of cancer within 5 years of malignancy currently under treatment
• inability to obtain informed consent
• previous or existing renal dysfunction, liver disease, or hepatic dysfunction
• pre-existing type I diabetes mellitus
• pregnancy
• allergy to metformin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Metformin	Drug: Metformin; Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.
Experimental: Insulin	Drug: Humulin R; Humulin R (U-100) will be given i.v. The dose given will be adjusted in order to achieve a blood glucose level of 130-140 mg/dl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perform oral glucose tolerance test	Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.	at 1-2 months post-admission, up to 6 months
Perform oral glucose tolerance test	Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.	assessed at discharge (1-4 months post admission depending on the severity of injury)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure concentrations of serum cytokines	Inflammatory response will be assessed by measuring the concentrations (in pg/ml)of a panel of serum cytokines (IL-1, IFN, TNF etc.) using the Bio-Plex 17-Plex Suspension assay.	weekly until discharge (1-4 months post admission depending on severity of injury)
Record the episodes of sepsis	Patients will be assessed daily for episodes of sepsis. The total number of episodes over the course of hospital stay will be recorded.	daily until discharge (1-4 months post admission depending on severity of injury)
Record the episodes of Pneumonia	Pneumonia is defined by new progressive and persistent infiltrate, consolidation or cavitations, inhalation injury based on chest X-ray. We will also follow the guidelines provided by the American Burn Association on the definition of Pneumonia in burn patients. Change in sputum (purulent or increased) will also be recorded.	daily until discharge (1-4 months post admission depending on severity of injury)

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Thermal injury; Chemical Burn; Flame Burn
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: ins_met_jeschke