the Association Between Obesity and Early Puberty | NCT04317014

Studies
the Association Between Obesity and Early Puberty

NCT04317014

Sponsor

Shenzhen Center for Disease Control and Prevention

Status

Completed

Last Update Posted

Mar 20, 2020Actual

Enrollment

628Actual

Phase

Not provided

Conditions

Early Puberty

Interventions

Not provided

Countries

Not provided

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

Mar 2020

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

Sep 1, 2016Actual

Primary Completion Date

May 20, 2018Actual

Completion Date

Jun 4, 2019Actual

First Submitted Date

Mar 17, 2020

First Submission Date that Met QC Criteria

Mar 18, 2020

First Posted Date

Mar 20, 2020Actual

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

Mar 18, 2020

Last Update Posted Date

Mar 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Di Li, post doctor, Shenzhen Center for Disease Control and PreventionPrincipal Investigator

Lead Sponsor

Shenzhen Center for Disease Control and PreventionOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

childhood obesity and early puberty are closely related, but existing reports usually focus on their relationship from the perspective of phenotype. This study was designed to investigate the association between obesity-related genic polymorphisms and the risk of early puberty in Chinese Han girls.

Detailed Description

the genotypes of obesity-related SNPs were determined and the unstimulated luteinizing hormone, follicle stimulating hormone and estradiol levels were also detected.

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

628Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases		early puberty girls of Han Chinese
controls		normal development girls of Han Chinese

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
genotypes of SNPs in the obesity-related genes	the obesity-related SNPs in the LRRN6C, MAF, CYP27A1 and ETV5 genes are selected and the genotypes of these SNPs are determined with a MassARRAY system.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of central precocious puberty or early and fast puberty.

Exclusion Criteria:

The participants who were not the first visit to the hospital and had been treated before.
The participants who were with endocrine disorders.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011629	Puberty, Precocious

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided