Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury

Project 4: Molecular Mechanisms in Burn-induced Insulin Resistance in Humans

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02029261

Enrollment

Registered

2014-01-07

Start date

2014-05-31

Completion date

2018-05-31

Last updated

2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

Keywords

Burn

Brief summary

The purpose of this study is to examine important and significant problems, that of insulin resistance and muscle wasting after burn injury.

Detailed description

Burn injury induces insulin resistance and our investigators have previous shown the importance of insulin receptor substrate 1 (IRS-1)-mediated pathways. This project will establish the inhibitory effects of burn injury on IRS-1 mediated signaling in human skeletal muscle of burn patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Burn injury \>=10% total body surface area involvement from any etiology that will require surgical treatment * Age 18 years or older * Admitted to the Massachusetts General Hospital within 30 days of burn injury * Patient or guardian who is capable of giving full informed consent

Exclusion criteria

* Decision not to treat due to severity of injury * Presence of anoxic brain injury that is not expected to result in complete recovery * Existence of co-morbid conditions of malignancy currently under treatment, medical condition requiring glucocorticoid treatment, insulin dependent diabetes mellitus, morbid obesity defined as body mass index \>= 40

Design outcomes

Primary

Measure	Time frame	Description
Determination of gene expression profile and protein expression	Time of burn injury up to 24 months postinjury	Determination of individual profiles and comparison with profiles from existing patients and healthy controls

Secondary

Measure	Time frame	Description
Hospital discharge status	From hospital admission to discharge	Alive or dead
Presence of clinical complications	From hospital admission to discharge	Analysis of incidence of clinical complications related to organ function/dysfunction
Intensive care unit (ICU) days	From hospital admission to discharge	Total number of ICU days
Nutritional status at discharge	At hospital discharge	Analysis of change in total body weight, lean body mass, indirect calorimetry, and nitrogen balance
Correlation between protein data and in vivo physiologic measurement data	Hospitalization	Gene and and protein expression data will be correlated with the physiological and and in vivo physiologic measurements (lab values) and nutritional status data.

Countries

United States

Outcome results