The Effects of Metformin on Morbidity and Mortality in Elderly Patients

Phase 2

Not yet recruiting

• Conditions: Burns
• Interventions: Drug: Placebos; Drug: Metformin

• Registration Number: NCT04530058
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Status Verified: 2023-12
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Study Start: 2024-11
• Primary Completion: 2028-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebos	-
Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Record episodes of pneumonia.	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 - Alanine transaminase (ALT)	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	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).
Record episodes of infection.	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 - Blood Urea Nitrogen (BUN)	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	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).
Record the episodes of sepsis.	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.
Organ function - Alkaline phosphatase (ALP)	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).
Record mortality	Acute hospitalization up to one year post burn.	Patient mortality will be recorded during hospitalization and outpatient follow-ups.

Secondary Outcome Measures

Name	Time	Method
Perform oral glucose tolerance test	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.
Measures of steady-state resting energy expenditure (REE)	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.

Trial Locations

Locations (1)

Hamilton Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada