Serum ANGPTL3, ANGPTL8 and Glypican 4 Concentrations in R... | NCT02389556

Studies
Serum ANGPTL3, ANGPTL8 and Glypican 4 Concentrations in Relation to the Development of Obesity in Korean Children

NCT02389556

Sponsor

Korea University

Status

Completed

Last Update Posted

Mar 1, 2016Estimated

Enrollment

457Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

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

Feb 2016

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 2006

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 10, 2015

First Submission Date that Met QC Criteria

Mar 10, 2015

First Posted Date

Mar 17, 2015Estimated

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

Feb 29, 2016

Last Update Posted Date

Mar 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kyung Mook Choi, Professor of Endocrinology and Metabolism in Korea university, Korea UniversityPrincipal Investigator

Lead Sponsor

Korea UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

ANGPTL3 and ANGPTL8 are emerging molecules involving lipid metabolism. In previous in vivo study using mice, ANGPTL8 regulated the activation of ANGPTL3 which was known to inhibit lipoprotein lipase activity and stimulate lipolysis of adipose tissue. Besides, glypican 4 was identified as a novel adipokine modulating adipocyte differentiation. Thus, the investigators postulated that different serum concentrations of ANGPTL3, ANGPTL8 and glypican 4 might affect progression of obesity in children. The investigators measure these molecules in Korean children, and investigate the association between these molecules and development of obesity.

Detailed Description

Participants in this study were selected from the Korean Metabolic disorders & Obesity Study in Elementary School children (KMOSES), the main aim of which was to comprehensively assess obesity-related metabolic risk factors and to evaluate clinical outcomes in Korean children prospectively. Korean children who were participated in a school-based health examination, were reexamined for the 3-year follow-up assessment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

457Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The changes of body mass index according to serum level of ANGPTL3, ANGPTL8 and glypican 4		Baseline and 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants who were reexamined for the 3 year follow-up assessment

Exclusion Criteria:

Participants who were not being available for the 3 year follow up assessment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Participants in this study were selected from the Korean Metabolic disorders & Obesity Study in Elementary School children (KMOSES).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung Mook Choi, MD	Department of Internal Medicine, Korea University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine, Korea University College of Medicine		Seoul	VD	152-703	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided