NCT02326480

Brief Summary

Identify news genetic causes of different type of obesity (syndromic, familial or isolated obesity) by highlighting new mutations or new implied genes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

5.9 years

First QC Date

December 15, 2014

Last Update Submit

March 2, 2020

Conditions

Keywords

Childhood ObesityGenetics

Outcome Measures

Primary Outcomes (1)

  • To identify the number of mutations or genes involved in genetic causes of Child obesity

    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 Outcomes (3)

  • To identify the number of mutations in the population

    first day of enrollement

  • To identify the number of new mutations present in the children's DNA and absent from their parents' genomes

    first day of enrollement

  • To determine number of phenotypes associated to the child obesity genotype

    first day of enrollement

Study Arms (3)

Syndromic obesity

Identification of genetic causes of obesity

Familial obesity

Identification of genetic causes of obesity

Other: Identification of genetic causes of obesity

Isolated obesity

Identification of genetic causes of obesity

Other: Identification of genetic causes of obesity

Interventions

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

Familial obesityIsolated obesity

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Three categories of obese children with their biological parents will be included (syndromic, familial, isolated obesity).

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Vincent de Paul

Lille, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

ObesityPediatric Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Louise Montagne

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    PRINCIPAL INVESTIGATOR
  • Philippe Froguel, MD, PhD

    UMR CNRS 8199, Institut Pasteur de Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lansiaux, MD, PhD

CONTACT

Mélanie Hamez

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 29, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations