Obesity, ChildhoodGREOLNCT04329260
Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity
An observational study of Obesity, Childhood, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
The objective of this study is to estimate the proportion of the recurrent deletion Δ6-8 of the LEPR gene in the homozygous and heterozygous state in pediatric cases with severe and early ( before the age of 6) obesity (BMI ≥ IOTF-30) on Reunion Island. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Obesity, Childhood
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Dec 2022
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children between 3 to 18 years old with severe obesity (BMI>30) and adult family members.
Who may be able to join
- patient with early severe and non syndromic obesity (BMI> IOTC-30) (before 6 years old)
- adult family members with deletion of LEPR gene
- informed consent form signed by participants or parents
- affiliation to social security scheme
Who cannot join
- patient with syndromic obesity
- patient Under guardianship or Under judicial protection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity GRÉOL (Génétique Réunion Obésité LEPR)
The objective of this study is to estimate the proportion of the recurrent deletion Δ6-8 of the LEPR gene in the homozygous and heterozygous state in pediatric cases with severe and early ( before the age of 6) obesity (BMI ≥ IOTF-30) on Reunion Island.
Read the detailed description
The study of the deletion Δ6-8 of the LEPR gene starts with a saliva sample using a swab in children aged between 3 to 18 years old.
The DNA from this sample will then be analyzed by the PCR technique. If the deletion of the LEPR gene is confirmed in the patient, his adult family members will also be screened using the same procedure.
- Conditions
- Obesity, Childhood
- Medical subject headings
- Pediatric Obesity
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 |
|---|---|---|
| Pediatric population | Children between 3 to 18 years old with severe (BMI> IOTF-30) and early (before the age of 6) obesity. A Saliva sample for screening of the deletion Δ6-8 of LEPR gene will be performed for each child. | |
| Adult member family | The screening of the same deletion according the same procedure will be proposed to the adult family member if the child presents the deletion Δ6-8 of LEPR gene. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the Δ6-8 deletion of the LEPR gene in paediatric population
Presence of the deletion of the LEPR gene
Measured: at inclusion
Secondary outcomes (1)
Proportion of the Δ6-8 deletion of the LEPR gene in adult family members
Presence of the deletion of the LEPR gene
Measured: 6 months after inclusion of the paediatric population
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study startMar 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul GUEGUEN, MD, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329260
- Sponsor's protocol ID
- 2019/CHU/04
- Acronym
- GREOL
- Status last verified
- Jan 2021
- First submitted
- 30 Mar 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity GRÉOL (Génétique Réunion Obésité LEPR)
- ClinicalTrials.gov ID
- NCT04329260
- Acronym / sponsor ID
- GREOL / 2019/CHU/04
- Conditions
- Obesity, Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Apr 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.
The objective of this study is to estimate the proportion of the recurrent deletion Δ6-8 of the LEPR gene in the homozygous and heterozygous state in pediatric cases with severe and early ( before the age of 6) obesity (BMI ≥ IOTF-30) on Reunion Island.
Detailed description
The study of the deletion Δ6-8 of the LEPR gene starts with a saliva sample using a swab in children aged between 3 to 18 years old.
The DNA from this sample will then be analyzed by the PCR technique. If the deletion of the LEPR gene is confirmed in the patient, his adult family members will also be screened using the same procedure.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric population | – | –Children between 3 to 18 years old with severe (BMI> IOTF-30) and early (before the age of 6) obesity. A Saliva sample for screening of the deletion Δ6-8 of LEPR gene will be performed for each child. |
| Adult member family | – | –The screening of the same deletion according the same procedure will be proposed to the adult family member if the child presents the deletion Δ6-8 of LEPR gene. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children between 3 to 18 years old with severe obesity (BMI>30) and adult family members.
Key inclusion criteria (4 listed)
- patient with early severe and non syndromic obesity (BMI> IOTC-30) (before 6 years old)
- adult family members with deletion of LEPR gene
- informed consent form signed by participants or parents
- affiliation to social security scheme
Key exclusion criteria (2 listed)
- patient with syndromic obesity
- patient Under guardianship or Under judicial protection
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
Proportion of the Δ6-8 deletion of the LEPR gene in paediatric population
Time frame: at inclusion
Presence of the deletion of the LEPR gene
1 secondary outcome
Proportion of the Δ6-8 deletion of the LEPR gene in adult family members
Time frame: 6 months after inclusion of the paediatric population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Obesity, Childhood
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
Paul GUEGUEN, MD principal investigator
CHU de La Réunion
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood, run by Centre Hospitalier Universitaire de la Réunion.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie TECHER (+262 262 90 62 89, emilie.techer@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the Δ6-8 deletion of the LEPR gene in paediatric population (time frame: at inclusion). 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 27 Jan 2021.