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The Effects of Metformin on Morbidity and Mortality in Elderly Patients

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ClinicalTrials.gov Identifier: NCT04530058
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Burns Drug: Metformin Drug: Placebos Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Metformin on Morbidity and Mortality in Elderly Patients- a Prospective Randomized Control Trial (RCT)
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Record mortality [ Time Frame: Acute hospitalization up to one year post burn. ]
    Patient mortality will be recorded during hospitalization and outpatient follow-ups.

  2. 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.

  3. 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.

  4. 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.

  5. Organ function - 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).

  6. Organ function - 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).

  7. 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).

  8. Organ function - 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: blood urea nitrogen (BUN) (mmol).

  9. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 60 - 99 years of age.
  2. ≥5% 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530058


Contacts
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Contact: Marc G Jeschke, MD PhD 416-480-6703 marc.jeschke@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marc G. Jeschke, MD PhD    416-480-6703      
Principal Investigator: Marc G. Jeschke, MD PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Marc G Jeschke, MD PhD Sunnybrook Health Sciences Centre
More Information
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04530058    
Other Study ID Numbers: 237-2016
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021

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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
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs