Observational Study of Insulin Resistance and Muscle Wast... | NCT02029261

Studies
Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury

NCT02029261

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Mar 7, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Burn

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2P50GM021700-32A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2018Actual

Completion Date

May 2018Actual

First Submitted Date

Dec 17, 2013

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2019

Last Update Posted Date

Mar 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ronald G. Tompkins, Chief, Burns Division, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Hospital discharge status	Alive or dead	From hospital admission to discharge
Presence of clinical complications	Analysis of incidence of clinical complications related to organ function/dysfunction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Massachusetts General Hospital (MGH) burn patients from the emergency department, intensive care unit, burn unit, or other MGH inpatient unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald G Tompkins, MD, ScD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data provided to the journal as required for publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided