- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04317014
the Association Between Obesity and Early Puberty
March 18, 2020 updated by: Di Li, Shenzhen Center for Disease Control and Prevention
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.
Study Overview
Status
Completed
Conditions
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 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 |
|---|
|
cases
early puberty girls of Han Chinese
|
|
controls
normal development girls of Han Chinese
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 4, 2019
Study Registration Dates
First Submitted
March 17, 2020
First Submitted That Met QC Criteria
March 18, 2020
First Posted (Actual)
March 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 20, 2020
Last Update Submitted That Met QC Criteria
March 18, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- szCDC_2
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.
Clinical Trials on Early Puberty
-
Children's Hospital of Fudan UniversityRecruiting
-
Chong Kun Dang PharmaceuticalSeverance HospitalNot yet recruitingEarly PubertyKorea, Republic of
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Isfahan University of Medical SciencesRecruitingPrecocious Puberty | Refraction Error | Early PubertyIran, Islamic Republic of
-
Kayseri City HospitalCompletedPuberty | Puberty Disorders | Central Precocious Puberty (CPP) | Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)Turkey (Türkiye)
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedCentral Precocious Puberty (CPP)Italy
-
AbbVieCompletedCentral Precocious Puberty (CPP)United States, Puerto Rico
-
Children's Hospital of Fudan UniversityTerminated
-
Debiopharm International SAActive, not recruitingCentral Precocious PubertyUnited States, Argentina, Brazil, Chile, Mexico
-
Foresee Pharmaceuticals Co., Ltd.QPS Holdings LLC; Changchun GeneScience Pharmaceutical Co., Ltd.Active, not recruitingPuberty; Precocious, CentralUnited States, China, Taiwan, Puerto Rico