Multi-frequency Bioelectrical Impedance for Estimating To... | NCT01607229

Studies
Multi-frequency Bioelectrical Impedance for Estimating Total Body Water by Deuterium Dilution

NCT01607229

Sponsor

University of Southern California

Status

Completed

Last Update Posted

May 30, 2012Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Total Body Water Assessment

Interventions

observation

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

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

May 8, 2012

First Submission Date that Met QC Criteria

May 24, 2012

First Posted Date

May 30, 2012Estimated

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

May 24, 2012

Last Update Posted Date

May 30, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Todd Schroeder, Assistant Professor of Clinical Physical Therapy, University of Southern CaliforniaPrincipal Investigator

Lead Sponsor

University of Southern CaliforniaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

SPECIFIC AIM:

Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium water (D2O) measurements.

HYPOTHESIS:

The Biospace Body Composition Analyzers are valid tools for measuring total body water and body composition.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
otherwise healthy with various BMI			Other: observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation	Other	no intervention used, observed measurements from 3 test devices compared to reference criterion measurement for total body water and body composition	otherwise healthy with various BMI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Body Water differences between criterion and test devices	from BIA and from D2O	Baseline only

Secondary Outcomes

Measure	Description	Time Frame
Total lean body mass differences between criterion and test devices	From BIA and from DXA	Baseline only
Appendicular lean mass differences between criterion and test devices	from BIA and from DXA

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men and women between 18-59 years of age

Exclusion Criteria:

Acute illness (infection, recent surgery, trauma).
pregnancy
pacemaker or defibrillator
We would like to standardize the procedures and measurements in the adult population first. Older adults are excluded because by including older adults at this time, we would need to increase the sample size because we believe older adults have greater fluctuations in hydration due to medications, diet, and co-morbidities.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California		Los Angeles	California	90033	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided