BurnsPhase 2MET-ELDNCT04530058
The Effects of Metformin on Morbidity and Mortality in Elderly Patients
A Phase 2 study testing Metformin in people with Burns, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. Elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.Glucose metabolism with insulin resistance is a… Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Burns
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2024to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 - 99 years of age.
- ≥5% total body surface area (TBSA) burn.
- Admitted to burn center ≤ 120 hours post-burn injury.
- At least one surgical intervention likely required.
- Provide written informed consent.
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.
- Pre-existing renal failure (eGFR is < 30 mL/min).
- Severe liver disease (Child-Pugh C).
- Pre-existing insulin-dependent type II diabetes.
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- Clinical contraindication to give metformin.
- Allergy to metformin or insulin.
- History of lactic acidosis while receiving metformin treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Hamilton Health Sciences Centre
Hamilton, Ontario, L8L 2X2
Marc G. Jeschke, MD PhD, 905-521-2100 ext. 40694, marc.jeschke@hhsc.ca
Marc G. Jeschke, MD PhD
About this study
Official title: The Effects of Metformin on Morbidity and Mortality in Elderly Patients- a Prospective Randomized Control Trial (RCT)
Elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. Elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.Glucose metabolism with insulin resistance is a hypermetabolic response pathway that profoundly affects post-burn outcomes. The aim if this study is to determine whether metformin can improve morbidity and mortality in elderly burn patients. The investigators hypothesize that metformin will improve clinical outcomes and mortality of elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burn.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 500 mg twice a day, administered orally or via gastric tube.
PlacebosDrug
Placebo twice a day, administered orally or via gastric tube.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Placebos |
| Metformin | Experimental | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record mortality
Patient mortality will be recorded during hospitalization and outpatient follow-ups.
Measured: Acute hospitalization up to one year post burn.
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 episodes of infection.
Patients will be assessed daily for episodes of infection. 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 episodes of pneumonia.
Patients will be assessed daily for episodes of infection. 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)]
Organ function - Alkaline phosphatase (ALP)
Organ function will be assessed by measuring the biomarker: ALP (U/L).
Measured: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function - Alanine transaminase (ALT)
Organ function will be assessed by measuring the biomarker: ALT (U/L).
Measured: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function - Bilirubin
Organ function will be assessed by measuring the biomarker: bilirubin (umol).
Measured: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function - Blood Urea Nitrogen (BUN)
Organ function will be assessed by measuring the biomarker: BUN (mmol).
Measured: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function - Creatinine
Organ function will be assessed by measuring the biomarker: creatinine (umol/L).
Measured: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Secondary outcomes (2)
Measures of steady-state resting energy expenditure (REE)
Metabolic response to injury and illness can be studied by measuring steady-state resting energy expenditure. Hypermetabolism is used as a secondary endpoint as stress-induced diabetes is associated with inflammation and hypermetabolism.
Measured: weekly until discharge if a patient is intubated and ventilated (1-4 months post admission depending on severity of injury)]
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: once at discharge from hospital (1-4 months post admission depending on the 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 posted28 Aug 2020
- Study startNov 2024 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc G Jeschke, MD PhD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530058
- Sponsor's protocol ID
- 15230
- Acronym
- MET-ELD
- Status last verified
- Dec 2023
- First submitted
- 28 Jul 2020
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metformin on Morbidity and Mortality in Elderly Patients- a Prospective Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT04530058
- Acronym / sponsor ID
- MET-ELD / 15230
- Conditions
- Burns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 28 Aug 2020 (actual)
- 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.
Elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. Elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.Glucose metabolism with insulin resistance is a hypermetabolic response pathway that profoundly affects post-burn outcomes. The aim if this study is to determine whether metformin can improve morbidity and mortality in elderly burn patients. The investigators hypothesize that metformin will improve clinical outcomes and mortality of elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebos |
| Metformin | Experimental | Drug: Metformin |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 60 - 99 years of age.
- ≥5% total body surface area (TBSA) burn.
- Admitted to burn center ≤ 120 hours post-burn injury.
- At least one surgical intervention likely required.
- Provide written informed consent.
Key exclusion criteria (9 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.
- Pre-existing renal failure (eGFR is < 30 mL/min).
- Severe liver disease (Child-Pugh C).
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 |
|---|---|---|
| MetforminMetformin 500 mg twice a day, administered orally or via gastric tube. | Drug | Metformin |
| PlacebosPlacebo twice a day, administered orally or via gastric tube. | Drug | Control |
Primary outcome
Record mortality
Time frame: Acute hospitalization up to one year post burn.
Patient mortality will be recorded during hospitalization and outpatient follow-ups.
Record the episodes of sepsis.
Time frame: daily until discharge (1-4 months post admission depending on severity of injury)]
Patients will be assessed daily for episodes of sepsis. The total number of episodes over the course of hospital stay will be recorded.
Record episodes of infection.
Time frame: daily until discharge (1-4 months post admission depending on severity of injury)]
Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded.
Record episodes of pneumonia.
Time frame: daily until discharge (1-4 months post admission depending on severity of injury)]
Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded.
Organ function - Alkaline phosphatase (ALP)
Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: ALP (U/L).
Organ function - Alanine transaminase (ALT)
Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: ALT (U/L).
Organ function - Bilirubin
Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: bilirubin (umol).
Organ function - Blood Urea Nitrogen (BUN)
Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: BUN (mmol).
Organ function - Creatinine
Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: creatinine (umol/L).
2 secondary outcomes
Measures of steady-state resting energy expenditure (REE)
Time frame: weekly until discharge if a patient is intubated and ventilated (1-4 months post admission depending on severity of injury)]
Perform oral glucose tolerance test
Time frame: once at discharge from hospital (1-4 months post admission depending on the severity of injury)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Marc G Jeschke, MD PhD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Burns, run by Hamilton Health Sciences Corporation 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Oct 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc G Jeschke, MD PhD (905-521-2100 ext. 40694, marc.jeschke@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record mortality (time frame: Acute hospitalization up to one year post burn.). The study lists 9 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 2 Oct 2024.