Study Stopped
Insufficient recruitment
Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury
Project 4: Molecular Mechanisms in Burn-induced Insulin Resistance in Humans
2 other identifiers
observational
N/A
1 country
1
Brief Summary
The purpose of this study is to examine important and significant problems, that of insulin resistance and muscle wasting after burn injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 7, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 7, 2019
March 1, 2019
4 years
December 17, 2013
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Hospital discharge status
From hospital admission to discharge
Presence of clinical complications
From hospital admission to discharge
Intensive care unit (ICU) days
From hospital admission to discharge
Nutritional status at discharge
At hospital discharge
Correlation between protein data and in vivo physiologic measurement data
Hospitalization
Eligibility Criteria
Massachusetts General Hospital (MGH) burn patients from the emergency department, intensive care unit, burn unit, or other MGH inpatient unit
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Biospecimen
whole blood, plasma, isolated leukocytes, skeletal muscle, fat, skin
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald G Tompkins, MD, ScD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Burns Division
Study Record Dates
First Submitted
December 17, 2013
First Posted
January 7, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
March 7, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
Data provided to the journal as required for publication