Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury

N/AWithdrawnNCT02029261

Massachusetts General Hospital

Overview

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

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.

Study Type

OBSERVATIONAL

Conditions

Burn

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Determination of gene expression profile and protein expression

Determination of individual profiles and comparison with profiles from existing patients and healthy controls

Time frame: Time of burn injury up to 24 months postinjury

Secondary Outcomes

Hospital discharge status

Alive or dead

Time frame: From hospital admission to discharge

Presence of clinical complications

Analysis of incidence of clinical complications related to organ function/dysfunction

Time frame: From hospital admission to discharge

Intensive care unit (ICU) days

Total number of ICU days

Time frame: From hospital admission to discharge

Nutritional status at discharge

Analysis of change in total body weight, lean body mass, indirect calorimetry, and nitrogen balance

Time frame: At hospital discharge

Correlation between protein data and in vivo physiologic measurement data

Gene and and protein expression data will be correlated with the physiological and and in vivo physiologic measurements (lab values) and nutritional status data.

Time frame: Hospitalization

Data from ClinicalTrials.gov

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