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NCT02029261 Clinical Trial

Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury

Burn Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02029261
Other study ID # P50GM021700P4_1
Secondary ID 2P50GM021700-32A
Status Withdrawn
Phase
First received
Last updated
Start date May 2014
Est. completion date May 2018

Study information
Verified date March 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determination of gene expression profile and protein expression Determination of individual profiles and comparison with profiles from existing patients and healthy controls Time of burn injury up to 24 months postinjury
Secondary Hospital discharge status Alive or dead From hospital admission to discharge
Secondary Presence of clinical complications Analysis of incidence of clinical complications related to organ function/dysfunction From hospital admission to discharge
Secondary Intensive care unit (ICU) days Total number of ICU days From hospital admission to discharge
Secondary Nutritional status at discharge Analysis of change in total body weight, lean body mass, indirect calorimetry, and nitrogen balance At hospital discharge
Secondary 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. Hospitalization
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