NCT01307306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

7 years

First QC Date

January 21, 2011

Last Update Submit

March 24, 2022

Conditions

Burns

Keywords

Thermal injuryChemical BurnFlame Burn

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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)

Study Arms (3)

Metformin

EXPERIMENTAL
Drug: Metformin

Insulin

EXPERIMENTAL
Drug: Humulin R

Control

NO INTERVENTION

Interventions

Humulin RDRUG

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.

Insulin
MetforminDRUG

Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.

Metformin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

BurnsBurns, Chemical

Interventions

InsulinMetformin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Marc G Jeschke, MD PhD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2011

First Posted

March 2, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

CA(1)