Measurements of Skin Physiological Parameters as Mean of... | NCT00487877

Studies
Measurements of Skin Physiological Parameters as Mean of Metabolic Assessment

NCT00487877

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jun 19, 2007Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Hungry-Satiation Situation

Interventions

SenseWear Pro3 Armband
i-button DS2191 H

Countries

Israel

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

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Not provided

Completion Date

Dec 2007Estimated

First Submitted Date

Jun 18, 2007

First Submission Date that Met QC Criteria

Jun 18, 2007

First Posted Date

Jun 19, 2007Estimated

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

Jun 18, 2007

Last Update Posted Date

Jun 19, 2007Estimated

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

To investigate the relationship between hungry-satiation situation including meal time and metabolism, skin temerature changing, simpathetic & para-simpathetic response To investigate the relashionship between hungry-satiation situation including meal time and heart rate

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years old
BMI: 22-30 Kg / m2

Exclusion Criteria:

Any unbalanced chronic disease
Any infection disease

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nachum Vaisman, Prof.	Contact	+972-524-266-596		vaisman@tasmc.health.gov.il

Overall Officials

Name	Affiliation	Role
Nachum Vaisman, Prof.	unaffiliation	Principal Investigator
Nachum Vaisman, Prof.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Unit of clinical Nutrition	Recruiting	Tel Aviv			Israel

Name	Type	Description	Arm Group Labels	Other Names
SenseWear Pro3 Armband	Device
i-button DS2191 H	Device