- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02326480
Genetic Analysis of Childhood Obesity (OSV)
March 2, 2020 updated by: Lille Catholic University
Identify news genetic causes of different type of obesity (syndromic, familial or isolated obesity) by highlighting new mutations or new implied genes
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amélie Lansiaux, MD, PhD
- Email: lansiaux.amelie@ghicl.net
Study Contact Backup
- Name: Mélanie Hamez
- Email: hamez.melanie@ghicl.net
Study Locations
-
-
-
Lille, France
- Recruiting
- Hopital Saint Vincent de Paul
-
Contact:
- Louise Montagne
-
-
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
6 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Three categories of obese children with their biological parents will be included (syndromic, familial, isolated obesity).
Description
Inclusion criteria:
- BMI > curve of IOTF 30 (International Obesity Task Force)
- Age: between 6 months old and 18 years old
- Child presenting syndromic, isolated or familial obesity.
Exclusion Criteria:
- Common obesity
- Impossibility for blood sampling
- Impossibility to receive information
- Participation refusal of one of the parents
- Refusal to sign the informed consent
- Neither Healthcare coverage nor insurance
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 |
---|---|
Syndromic obesity
Identification of genetic causes of obesity
|
|
Familial obesity
Identification of genetic causes of obesity
|
A blood test will be performed to the child and his/her parents with the aim of identifying genetic causes of obesity.
Different analysis will be as follows: caryotypes, Raindance, whole exome, in order to find potential mutations or new genes associated to this condition
|
Isolated obesity
Identification of genetic causes of obesity
|
A blood test will be performed to the child and his/her parents with the aim of identifying genetic causes of obesity.
Different analysis will be as follows: caryotypes, Raindance, whole exome, in order to find potential mutations or new genes associated to this condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify the number of mutations or genes involved in genetic causes of Child obesity
Time Frame: first day of enrollement
|
Children with obesity and their parents will be recruited to establish genetic causes of obesity.
This will allow perform genetic analysis using new approaches for the identification of involved mutations or new candidate genes
|
first day of enrollement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify the number of mutations in the population
Time Frame: first day of enrollement
|
first day of enrollement
|
|
To identify the number of new mutations present in the children's DNA and absent from their parents' genomes
Time Frame: first day of enrollement
|
This approach will allow the identification of specific mutations that are present only in affected children but not in their parents
|
first day of enrollement
|
To determine number of phenotypes associated to the child obesity genotype
Time Frame: first day of enrollement
|
first day of enrollement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Louise Montagne, Groupement des Hôpitaux de l'Institut Catholique de Lille
- Principal Investigator: Philippe Froguel, MD, PhD, UMR CNRS 8199, Institut Pasteur de Lille
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
January 1, 2015
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
December 15, 2014
First Submitted That Met QC Criteria
December 22, 2014
First Posted (Estimate)
December 29, 2014
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-P0036
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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