Monogenic ObesityOBEGENENCT05362565
Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity
An observational study of Monogenic Obesity, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Monogenic Obesity
- What is being tested?
- Salivary Sampling
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2022to 1 Jan 2024
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient with a Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5.
Who may be able to join
- Recruitment age: 2-17 years
- Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5
- Care at the specialized pediatric obesity center (CSO) of the Bordeaux University Hospital
- Informed consent signed
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Wafae BELCADI contact
France1 site
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33400
Louis Lebreton, louis.lebreton@chu-bordeaux.fr
Wafae Belcadi, wafae.belcadi@chu-bordeaux.fr
About this study
Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.
- Conditions
- Monogenic Obesity
- Being tested
- Salivary Sampling
- Keywords
- monogenic obesity, pediatric, early onset obesity, genetic disease
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary SamplingBiological
The DNA study will be carried out from saliva sample
1 saliva sample per patient will be performed at the inclusion visit
| Study group | Role | What they receive |
|---|---|---|
| Patient with salivary sampling | Not described Receives: Biological: Salivary Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed.
Measured: Inclusion visit
Secondary outcomes (2)
Number of Patients eligible for a drug targeting single-gene obesity
Measured: Inclusion visit
Number of patients for whom a genetic finding will have changed management and description of changes.
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monogenic ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362565
- Sponsor's protocol ID
- CHUBX 2021/55
- Acronym
- OBEGENE
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 5 May 2022
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity
- ClinicalTrials.gov ID
- NCT05362565
- Acronym / sponsor ID
- OBEGENE / CHUBX 2021/55
- Conditions
- Monogenic Obesity
- Keywords
- monogenic obesity, pediatric, early onset obesity, genetic disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 5 May 2022 (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.
Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with salivary sampling | – | Biological: Salivary Sampling |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient with a Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5.
Key inclusion criteria (4 listed)
- Recruitment age: 2-17 years
- Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5
- Care at the specialized pediatric obesity center (CSO) of the Bordeaux University Hospital
- Informed consent signed
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary SamplingThe DNA study will be carried out from saliva sample 1 saliva sample per patient will be performed at the inclusion visit | Biological | Patient with salivary sampling |
Primary outcome
Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed.
Time frame: Inclusion visit
2 secondary outcomes
Number of Patients eligible for a drug targeting single-gene obesity
Time frame: Inclusion visit
Number of patients for whom a genetic finding will have changed management and description of changes.
Time frame: Inclusion visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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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.
Wafae BELCADI contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monogenic Obesity, run by University Hospital, Bordeaux at 1 site in France.
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 1 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 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Louis LEBRETON (05 57 82 21 78, louis.lebreton@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed. (time frame: Inclusion visit). 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 5 May 2022.