Kisspeptin/GPR54 Pathway and Early Puberty

July 9, 2019 updated by: Di Li, Shenzhen Center for Disease Control and Prevention

Polymorphisms in the Kisspeptin/GPR54 Pathway Genes and the Risk of Early Puberty

There was a worldwide early trend in girls'age for puberty onset. The timing of puberty onset varies greatly among individuals, and much of this variation is modulated by genetic factors. This study was designed to explored the association of polymorphisms in KISS1/GPR54 pathway genes and the risk of early puberty in Chinese Han girls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

628

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cases
Early puberty cases of Han Chinese
controls
Controls were matched to cases at 1:1 by age (± 3 months)
Other: this study was an observational study and no interventions were given to the participants
the participants were recruited and the data as well as blood sample were collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the polymorphism in the KISS1/GPR54 pathway genes
Time Frame: 3 months
functional SNP loci of the KISS1/GPR54 pathway genes KISS1, KISSIR, PLCB1, PRKCA, and ITPR1 were selected and detected.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Center for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

May 20, 2018

Study Completion (ACTUAL)

July 4, 2019

Study Registration Dates

First Submitted

July 5, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (ACTUAL)

July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • szCDC_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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