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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas, Galveston
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01666665
First received: August 6, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

Massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. Insulin and metformin have demonstrated anabolic activity with minimal associated side effects. However, it is unknown whether the beneficial effects arise from tight euglycemic control or direct effect of insulin action. We hypothesize that during acute hospitalization, administration of metformin at a dose titrated to maintain blood glucose between 80-180 mg/dl will accelerate wound healing and recovery in children with severe thermal injury and will have beneficial long-term effects on muscle strength, immune function, and wound healing.


Condition Intervention Phase
Insulin Resistance
Hypermetabolism
Hyperglycemia
Drug: Metformin
Drug: Sugar pill
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Insulin resistance [ Time Frame: Measure changes between admission and 2 years post burn ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Protein synthesis [ Time Frame: Measure changes between admission and 2 years post burn ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: Measure changes between admission and 2 years post burn ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metformin
Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months
Drug: Metformin
Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months
Other Name: glucophage
Placebo Comparator: Sugar pill
sugar pill up to 3 times per day for 12 months
Drug: Sugar pill
Sugar pill up to 3 times per day for 12 months
Other Name: placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age 10-19
  • Primary diagnosis of ≥ 20 TBSAB (Total Burn Surface Area Burn)

Exclusion Criteria:

  • Decision not to treat due to burn injury severity
  • Known history of AIDS, ARC, HIV
  • Pregnancy
  • persistent lactic acidosis
  • Previous existing renal failure, liver disease or hepatic dysfunction (Bilirubin >3mg/dL, SGOT >40u/L, GPT >51u/L serum Creatinine >3mg/dL after fluid resuscitation
  • Pre-existing type 1 diabetes mellitus
  • Allergies to Metformin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666665

Contacts
Contact: Catherine Reed, RN, BSN 409-770-6987 ca2reed@utmb.edu
Contact: Deb Benjamin, RN, MSN 409-770-6731 dbenjami@utmb.edu

Locations
United States, Texas
Shriners Hospitals for Children Recruiting
Galveston, Texas, United States, 77551
Contact: Cathy Reed, BSN    409-770-6987    ca2reed@utmb.edu   
Contact: Deb Benjamin, MSN    409-770-6731    dbenjami@utmb.edu   
Principal Investigator: David N Herndon, MD         
Sub-Investigator: Oscar Suman, PhD         
Sponsors and Collaborators
The University of Texas, Galveston
Shriners Hospitals for Children
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01666665     History of Changes
Other Study ID Numbers: 12-142
Study First Received: August 6, 2012
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas, Galveston:
Burn

Additional relevant MeSH terms:
Insulin Resistance
Hyperglycemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014