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Anti-diabetic drug

Metformin for Burns (MET-ELD Trial)

Phase 2
Waitlist Available
Led By Marc G Jeschke, MD PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥5% total body surface area (TBSA) burn
At least one surgical intervention likely required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up acute hospitalization up to one year post burn.
Awards & highlights

MET-ELD Trial Summary

This trial will test whether metformin can help improve outcomes for elderly people who have suffered burns, by lessening the complex inflammatory and hypermetabolic responses that can occur after a burn injury.

Who is the study for?
This trial is for elderly patients aged 60-99 with significant burn injuries, who are likely to need surgery and can consent to treatment. They must have a burn covering at least 5% of their body but cannot join if they're critically ill on admission, have severe pre-existing conditions like kidney or liver failure, allergies to metformin, or a history of lactic acidosis with metformin.Check my eligibility
What is being tested?
The study tests whether the drug Metformin reduces complications and death rates in elderly patients with burns compared to a placebo. The hypothesis is that Metformin will help manage the intense inflammatory and metabolic reactions following a burn injury.See study design
What are the potential side effects?
Metformin may cause side effects such as digestive issues (nausea, diarrhea), potential vitamin B12 deficiency over time, and very rarely, an increased risk of lactic acidosis—a serious metabolic complication.

MET-ELD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have burns covering 5% or more of my body.
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I will likely need surgery.
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I am between 60 and 99 years old.

MET-ELD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~acute hospitalization up to one year post burn.
This trial's timeline: 3 weeks for screening, Varies for treatment, and acute hospitalization up to one year post burn. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Organ function - Alanine transaminase (ALT)
Organ function - Alkaline phosphatase (ALP)
Organ function - Bilirubin
+6 more
Secondary outcome measures
Measures of steady-state resting energy expenditure (REE)
Perform oral glucose tolerance test

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

MET-ELD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,372 Total Patients Enrolled
5 Trials studying Burns
236 Patients Enrolled for Burns
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,743 Total Patients Enrolled
3 Trials studying Burns
169 Patients Enrolled for Burns
Marc G Jeschke, MD PhDPrincipal InvestigatorHamilton Health Sciences Corporation
4 Previous Clinical Trials
194 Total Patients Enrolled
4 Trials studying Burns
194 Patients Enrolled for Burns

Media Library

Metformin (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT04530058 — Phase 2
Burns Research Study Groups: Control, Metformin
Burns Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04530058 — Phase 2
Metformin (Anti-diabetic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530058 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enrolled in this clinical investigation?

"Affirmative. Data posted on clinicaltrials.gov supports the notion that this medical trial, which was initially advertised on January 28th 2021 is recruiting participants at present. Around 250 people need to be recruited from a single location."

Answered by AI

Is Metformin a novel or well-studied treatment option?

"At present, there are 170 current studies on Metformin with 43 of these trials in their third and final phase. Primarily located in Pittsburgh, Pennsylvania, 1903 distinct sites are participating in these investigations."

Answered by AI

Are elderly individuals in their golden years eligible for this experiment?

"The trial has stringent eligibility requirements and only admits patients aged 60-99. There are 40 openings for those younger than 18 years old, while 190 slots are allocated to those over 65."

Answered by AI

In what conditions is Metformin typically prescribed?

"Metformin has a wide range of applications, from treating exercise to managing type 1 diabetes mellitus, diabetic ketoacidosis and polycystic ovary syndrome."

Answered by AI

Are there any openings remaining for this clinical assessment?

"As indicated by records on clinicaltrials.gov, this medical trial is currently enrolling participants. The experiment was initially made accessible to the public on January 28th 2021 and underwent its most recent revision in March 24th 2022."

Answered by AI

What adverse effects might patients experience from Metformin use?

"Taking into account the limited evidence of its efficacy, our team deemed Metformin's safety to rate a 2."

Answered by AI

Who is eligible to partake in this clinical experiment?

"This trial is looking to recruit 250 patients, aged 60-99 years old, with burns that cover 5% or more of their Total Body Surface Area (TBSA). Furthermore, they must have been admitted to a burn centre within 120 hours of the injury and require at least one surgical intervention."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effects of Metformin on Morbidity and Mortality in Elderly Patients
2024. "The Effects of Metformin on Morbidity and Mortality in Elderly Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04530058.
~167 spots leftby Mar 2028
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