The Incidence of Metabolic Syndrome Among Obese Children... | NCT01466556

Studies
The Incidence of Metabolic Syndrome Among Obese Children in Our Region

NCT01466556

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Nov 8, 2011Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Metabolic Syndrome

Interventions

Routine laboratory tests

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

Nov 2011

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

Nov 2011

Primary Completion Date

Aug 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Nov 3, 2011

First Submission Date that Met QC Criteria

Nov 7, 2011

First Posted Date

Nov 8, 2011Estimated

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

Nov 7, 2011

Last Update Posted Date

Nov 8, 2011Estimated

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

The aim of this study is to determine the prevalence of metabolic syndrome amongst obese children in our region with a body mass index (BMI) above the 95th percentile for age and sex.

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obese children			Other: Routine laboratory tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine laboratory tests	Other	Laboratory tests to determine metabolic syndrome	Obese children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of children with metabolic syndrome		six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with BMI over 95 percentile

Exclusion Criteria:

Obesity secondary to medication use
Obesity secondary to genetic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children who visit our outpatient clinic or a routine visit to the ER

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Renata Yaacobov, MD	Contact	972-050-624-6969		renatay@hy.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center	Recruiting	Hadera			Israel

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided