Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Perform oral glucose tolerance test
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Metformin
Intervention: Metformin (Drug)
Insulin
Intervention: Humulin R (Drug)
Outcomes
Primary Outcomes
Perform oral glucose tolerance test
Time Frame: assessed at discharge (1-4 months post admission depending on the severity of injury)
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 Outcomes
- Measure concentrations of serum cytokines(weekly until discharge (1-4 months post admission depending on severity of injury))
- Record the episodes of sepsis(daily until discharge (1-4 months post admission depending on severity of injury))
- Record the episodes of Pneumonia(daily until discharge (1-4 months post admission depending on severity of injury))
Investigators
Dr. Marc Jeschke
Principal Investigator
Sunnybrook Health Sciences Centre