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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

January 21, 2011
January 29, 2013
March 2011
March 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01307306 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Burns
  • 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.
  • Drug: Metformin
    Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.
  • Experimental: Metformin
    Intervention: Drug: Metformin
  • Experimental: Insulin
    Intervention: Drug: Humulin R
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
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
Canada
 
NCT01307306
ins_met_jeschke
No
Dr. Marc Jeschke, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Not Provided
Principal Investigator: Marc G Jeschke, MD PhD Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP