Risk Factors Related to Metabolic Syndrome in School-aged... | NCT02746887

Studies
Risk Factors Related to Metabolic Syndrome in School-aged Children Who Were Born Preterm

NCT02746887

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Apr 21, 2016Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Metabolic Syndrome

Interventions

Preterm/term cohort

Countries

South Korea

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

Apr 2016

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

Dec 2015

Primary Completion Date

Nov 2016Estimated

Completion Date

Not provided

First Submitted Date

Dec 9, 2015

First Submission Date that Met QC Criteria

Apr 18, 2016

First Posted Date

Apr 21, 2016Estimated

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

Apr 18, 2016

Last Update Posted Date

Apr 21, 2016Estimated

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

This is a follow-up cohort study of 8 years old children born preterm at Seoul National University Children's Hospital in Korea from 2008-2009.

The children will visit outpatient clinics for examinations regarding growth, obesity and other risk factors related to metabolic syndrome.

The purpose of this study is to compare growth and risk factors of metabolic syndrome among children born preterm and children born healthy term at school age

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

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preterm cohort		Preterm infants with a gestational age less than 32 weeks or birth weight less than 1,500 g	Other: Preterm/term cohort
Term control cohort		Healthy term infants	Other: Preterm/term cohort

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preterm/term cohort	Other		Preterm cohort Term control cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of participants with abnormal laboratory values and/or abnormal physical status		at 8 years corrected age

Secondary Outcomes

Measure	Description	Time Frame
The number of participants with catch-up growth failure		at 8 years corrected age
The number of participants with hypertension		at 8 years corrected age

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Very low birth weight infants and/or born less than 32 weeks of gestation age
Healthy term infants for control group
Parents and children accept of participation

Exclusion Criteria:

Major congenital anomalies
Neuromuscular disease
Chromosomal anomalies
Patients receiving growth hormone therapy
Primary hypothyroidism

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

school aged children who were born preterm with a gestational age less than 32 weeks or a birth weight less than 1,500 g
school aged children who were born healthy term

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seung Han Shin, MD	Contact	+82-02-2072-7230		revival421@snu.ac.kr
Young Hwa Jung, MD	Contact	+82-02-2072-3553		jyhtlcn@gmail.com

Overall Officials

Name	Affiliation	Role
Seung Han Y Shin, MD	Seoul National University Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seung Han Shin	Recruiting	Seoul		110-744	South Korea

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