NCT04317014

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
628

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

March 17, 2020

Last Update Submit

March 18, 2020

Conditions

Early Puberty

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

cases

early puberty girls of Han Chinese

controls

normal development girls of Han Chinese

Eligibility Criteria

Age7 Years - 10 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post doctor

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 20, 2020

Study Start

September 1, 2016

Primary Completion

May 20, 2018

Study Completion

June 4, 2019

Last Updated

March 20, 2020

Record last verified: 2020-03