The Effects of Metformin on Morbidity and Mortality in Elderly Patients

NCT04530058 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-10-02

No results posted yet for this study

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.

Conditions

  • Burns

Interventions

DRUG

Metformin

Metformin 500 mg twice a day, administered orally or via gastric tube.

DRUG

Placebos

Placebo twice a day, administered orally or via gastric tube.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Marc G Jeschke, MD PhD · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2028-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530058 on ClinicalTrials.gov