Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury

Withdrawn

• Conditions: Burn

• Registration Number: NCT02029261
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Study Start: 2014-05
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Presence of clinical complications	From hospital admission to discharge	Analysis of incidence of clinical complications related to organ function/dysfunction
Hospital discharge status	From hospital admission to discharge	Alive or dead
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.
Nutritional status at discharge	At hospital discharge	Analysis of change in total body weight, lean body mass, indirect calorimetry, and nitrogen balance
Intensive care unit (ICU) days	From hospital admission to discharge	Total number of ICU days

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States