Glucose Control in Severely Burned Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Dr. Marc Jeschke, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01307306
First received: January 21, 2011
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Burns
Drug: Humulin R
Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Perform oral glucose tolerance test [ Time Frame: at 1-2 months post-admission, up to 6 months ] [ Designated as safety issue: No ]
    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.

  • Perform oral glucose tolerance test [ Time Frame: assessed at discharge (1-4 months post admission depending on the severity of injury) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Measure concentrations of serum cytokines [ Time Frame: weekly until discharge (1-4 months post admission depending on severity of injury) ] [ Designated as safety issue: No ]
    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.

  • Record the episodes of sepsis [ Time Frame: daily until discharge (1-4 months post admission depending on severity of injury) ] [ Designated as safety issue: No ]
    Patients will be assessed daily for episodes of sepsis. The total number of episodes over the course of hospital stay will be recorded.

  • Record the episodes of Pneumonia [ Time Frame: daily until discharge (1-4 months post admission depending on severity of injury) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01307306

Contacts
Contact: Marc G Jeschke, MD PhD 416-480-6703 marc.jeschke@sunnybrook.ca
Contact: Marjorie A Burnett, HonsBSc 416-480-6100 ext 88021 marjorie.burnett@sunnybrook.ca

Locations
Canada, Ontario
Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marc G Jeschke, MD PhD    416-480-6703    marc.jeschke@sunnybrook.ca   
Contact: Marjorie Burnett, HonsBSc    416-480-6100 ext 88021    marjorie.burnett@sunnybrook.ca   
Sub-Investigator: Robert Cartotto, MD         
Sub-Investigator: Shahriar Shahrokhi, MD         
Sub-Investigator: Alison Cheung, PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Marc G Jeschke, MD PhD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Marc Jeschke, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01307306     History of Changes
Other Study ID Numbers: ins_met_jeschke
Study First Received: January 21, 2011
Last Updated: January 29, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Thermal injury
Chemical Burn
Flame Burn

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

ClinicalTrials.gov processed this record on July 23, 2014