NCT01466556

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

November 3, 2011

Last Update Submit

November 7, 2011

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Incidence of children with metabolic syndrome

    six months

Study Arms (1)

Obese children

Other: Routine laboratory tests

Interventions

Routine laboratory testsOTHER

Laboratory tests to determine metabolic syndrome

Obese children

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Children with BMI over 95 percentile

You may not qualify if:

  • Obesity secondary to medication use
  • Obesity secondary to genetic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, Israel

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Renata Yaacobov, MD

CONTACT

972-050-624-6969renatay@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 8, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

IL(1)