BurnsNCT01307306
Glucose Control in Severely Burned Patients
A study testing Humulin R and Metformin in people with Burns, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Burns
- What is being tested?
- Humulin R and Metformin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- previous or existing renal dysfunction, liver disease, or hepatic dysfunction
- pre-existing type I diabetes mellitus
- pregnancy
- allergy to metformin
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MetforminDrug
Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Not described Receives: Drug: Metformin |
| Insulin | Experimental | Not described Receives: Drug: Humulin R |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: assessed at discharge (1-4 months post admission depending on the severity of injury)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: daily until discharge (1-4 months post admission depending on severity of injury)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marc Jeschke, Sunnybrook Health Sciences Centre
- Investigators
- Marc G Jeschke, MD PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307306
- Sponsor's protocol ID
- ins_met_jeschke
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2011
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential
- ClinicalTrials.gov ID
- NCT01307306
- Acronym / sponsor ID
- ins_met_jeschke
- Conditions
- Burns
- Keywords
- Thermal injury, Chemical Burn, Flame Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin |
| Insulin | Experimental | Drug: Humulin R |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humulin RHumulin 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 | Insulin |
| MetforminMetformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl. | Drug | Metformin |
Primary outcome
Perform oral glucose tolerance test
Time frame: at 1-2 months post-admission, up to 6 months
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)
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.
3 secondary outcomes
Measure concentrations of serum cytokines
Time frame: weekly until discharge (1-4 months post admission depending on severity of injury)
Record the episodes of sepsis
Time frame: daily until discharge (1-4 months post admission depending on severity of injury)
Record the episodes of Pneumonia
Time frame: daily until discharge (1-4 months post admission depending on severity of injury)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc G Jeschke, MD PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humulin R and Metformin in people with Burns, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perform oral glucose tolerance test (time frame: at 1-2 months post-admission, up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.