Early PubertyNCT04317014
the Association Between Obesity and Early Puberty
An observational study of Early Puberty, run by Shenzhen Center for Disease Control and Prevention.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Puberty
- How many people
- 628 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 4 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen
Who may be able to join
- Clinical diagnosis of central precocious puberty or early and fast puberty.
Who cannot join
- The participants who were not the first visit to the hospital and had been treated before.
- The participants who were with endocrine disorders.
About this study
Official title: Polymorphisms in Obesity-related Genes Are Associated With Risk of Early Puberty in Han Chinese Girls
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.
Read the detailed description
the genotypes of obesity-related SNPs were determined and the unstimulated luteinizing hormone, follicle stimulating hormone and estradiol levels were also detected.
- Conditions
- Early Puberty
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cases | early puberty girls of Han Chinese | |
| controls | normal development girls of Han Chinese |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Sep 2016
- Primary completion20 May 2018
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PubertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Di Li, Shenzhen Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317014
- Sponsor's protocol ID
- szCDC_2
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms in Obesity-related Genes Are Associated With Risk of Early Puberty in Han Chinese Girls
- ClinicalTrials.gov ID
- NCT04317014
- Acronym / sponsor ID
- szCDC_2
- Conditions
- Early Puberty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Shenzhen Center for Disease Control and PreventionOther government
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | –early puberty girls of Han Chinese |
| controls | – | –normal development girls of Han Chinese |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen
Key inclusion criteria (1 listed)
- Clinical diagnosis of central precocious puberty or early and fast puberty.
Key exclusion criteria (2 listed)
- The participants who were not the first visit to the hospital and had been treated before.
- The participants who were with endocrine disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
genotypes of SNPs in the obesity-related genes
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Puberty, run by Shenzhen Center for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genotypes of SNPs in the obesity-related genes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020; AzTrials last refreshed its copy on 31 Oct 2026.