The Effects of Metformin on Morbidity and Mortality in Elderly Patients (MET-ELD)

September 30, 2024 updated by: Hamilton Health Sciences Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences Centre
        • Contact:
        • Contact:
          • Marc G. Jeschke, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 60 - 99 years of age.
  2. ≥5% total body surface area (TBSA) burn.
  3. Admitted to burn center ≤ 120 hours post-burn injury.
  4. At least one surgical intervention likely required.
  5. Provide written informed consent.

Exclusion Criteria:

  1. Death upon admission.
  2. Decision not to treat due to burn injury severity.
  3. Presence of anoxic brain injury that is not expected to result in complete recovery.
  4. Pre-existing renal failure (eGFR is < 30 mL/min).
  5. Severe liver disease (Child-Pugh C).
  6. Pre-existing insulin-dependent type II diabetes.
  7. Clinical contraindication to give metformin.
  8. Allergy to metformin or insulin.
  9. History of lactic acidosis while receiving metformin treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Drug: Placebos
Placebo twice a day, administered orally or via gastric tube.
Experimental: Metformin
Drug: Metformin
Metformin 500 mg twice a day, administered orally or via gastric tube.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Record mortality
Time Frame: Acute hospitalization up to one year post burn.
Patient mortality will be recorded during hospitalization and outpatient follow-ups.
Acute hospitalization up to one year post burn.
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.
daily until discharge (1-4 months post admission depending on severity of injury)]
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.
daily until discharge (1-4 months post admission depending on severity of injury)]
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.
daily until discharge (1-4 months post admission depending on severity of injury)]
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).
twice weekly until discharge (1-4 months post admission depending on severity of injury)]
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).
twice weekly until discharge (1-4 months post admission depending on severity of injury)]
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).
twice weekly until discharge (1-4 months post admission depending on severity of injury)]
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).
twice weekly until discharge (1-4 months post admission depending on severity of injury)]
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).
twice weekly until discharge (1-4 months post admission depending on severity of injury)]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)]
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.
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)]
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.
once at discharge from hospital (1-4 months post admission depending on the severity of injury)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamilton Health Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc G Jeschke, MD PhD, Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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