Suspended

Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Metformin

+ Sugar pill

Drug
Who is being recruted

Hyperinsulinism+5

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 10 to 19 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorThe University of Texas Medical Branch, Galveston
Last updated: November 29, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

Metformin treated patients will be compared to control patients. Both groups will receive insulin therapy for blood glucose >180mg/dl. Insulin will be titrated according to hospital sliding scale. The use of insulin or metformin will benefit burned children by improving muscle protein build-up, speeding wound healing and reversing growth arrest, improving the immune response, and positively affecting long-term rehabilitation. The results of this study may initiate a change in standard of care as it is found that simply the reduction of blood glucose by metformin, improves patient outcomes as metformin can be administered without the added complication of hypoglycemia.

NCT01666665
Principal SponsorThe University of Texas Medical Branch, Galveston
Last updated: November 29, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperinsulinismMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesGlucose Metabolism DisordersBurnsHyperglycemiaInsulin Resistance

Criteria

2 inclusion criteria required to participate
Patient age 10-19
Primary diagnosis of >= 20 Total Burn Surface Area Burn (TBSAB )
8 exclusion criteria prevent from participating
Acute or chronic acidosis (lactic or any other metabolic type) and renal failure
Allergies to Metformin
Decision not to treat due to burn injury severity
Known history of AIDS, ARC, HIV
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months

Group II

Placebo
sugar pill up to 3 times per day for 12 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Shriners Hospitals for Children

Galveston, United StatesOpen Shriners Hospitals for Children in Google Maps
SuspendedOne Study Center