Obesity, ChildOBEGENNCT05938335
Sequencing of 14 Genes From Leptin Melanocortin Pathway in Severe Obesity in Childhood.
A study testing sequencing of a panel of 14 genes in leptin melanocortin pathway in people with Obesity, Child, run by Central Hospital, Nancy, France.
Trial summary
About 380 million children and adolescents suffer from overweight and obesity at the global level. Obesity results from the interplay between biological (sex, age, fetal programming, gut microbiota, epigenetics, and genetics) and environmental factors (e.g., unhealthy diet, physical inactivity, stress). Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Obesity, Child
- What is being tested?
- sequencing of a panel of 14 genes in leptin melanocortin pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Jan 2025
- Phase
- Interventional
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- severe obesity with BMI > 3SDS
Who cannot join
- genetic obesity (Prader Willi syndrome, Bardet Biedl syndrome, X fragile syndrome, Alstrom syndrome)
- BMI < 3 SDS
- age < 6 months
- monogenic non syndromic obesity, with mutation in genes of leptin melanocortin pathway previously diagnosed
- cushing syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Results of Sequencing of a Large Panel of Genes From Leptin Melanocortin Pathway in Children Suffering From Severe Obesity
About 380 million children and adolescents suffer from overweight and obesity at the global level. Obesity results from the interplay between biological (sex, age, fetal programming, gut microbiota, epigenetics, and genetics) and environmental factors (e.g., unhealthy diet, physical inactivity, stress). Mutations in genes from leptin melanocortin pathway are involved in "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. Exact frequencies of mutation in these genes are not precisely evaluated in french children with severe obesity. Moreover new treatment, such seltmelanotide are avalaible in case of certain mutation, leading to a significative weight loss in treated patients.
Read the detailed description
Obesity is a global health concern that affected more than 650 million adult people and more than 380 million children and adolescents worldwide, with no signs of slowing down despite major investments in health policy. Obestiy is a multifactorial disease, but 40 to 75% of body mass index (BMI) variation is explained by genetic factors.
Mutations in genes from leptin melanocortin pathway lead to "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. This pathway plays a central role in regulating mammalian food intake, energy expenditure and body weight regulation. Somes genes are well characterized such LEP gene, LEPR gene, or MC4R but others have been recently described as ADCY3, SIM1, SH2B1, NTRK2, BDNF, KSR2.
The frequency of these mutations are not precisely estimated in a group of french children with severe obesity.
Moreover, a precocious identification of these mutations, could afford, in certain case the possibility of a efficient treatment with setmelanotide, leading to a significant weight loss in treated patients.
- Conditions
- Obesity, Child
- Being tested
- sequencing of a panel of 14 genes in leptin melanocortin pathway
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequencing of a panel of 14 genes in leptin melanocortin pathwayGenetic
sequencing (NGS) of a panel of 14 genes in leptin melanocortin pathway in french children with severe obesity
| Study group | Role | What they receive |
|---|---|---|
| severe obese children | Experimental | children with severe obesity with BMI > 3sds Receives: Genetic: sequencing of a panel of 14 genes in leptin melanocortin pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of mutations of genes from leptin melanocortin pathway
Evaluating of the frequency of mutations of 14 genes from leptin melanocortin pathway (LEP, LEPR, POMC, PCSK1, MC3R, MC4R, MRAP2, ADCY3, SIM1, SH2B1, NTRK2, BDNF, KSR2) in a group of french children with severe obesity.
Measured: 1 year
Secondary outcomes (12)
Clinical characteristics of children with severe obesity followed in CHRU of Nancy
Description of the clinical characteristics : height in cm BMI
Measured: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Description of the clinical characteristics :thyroid function (TSH T3 T4)
Measured: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Description of the clinical characteristics : IGF1 levels
Measured: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Description of the clinical characteristics :BMI in kg/m²
Measured: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Description of the clinical characteristics : weight in kg
Measured: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Description of the clinical characteristics : bone age (X ray of the left hand)
Measured: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Description of the clinical characteristics : metabolic profile
Measured: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Description of the clinical characteristics : leptin level
Measured: 1 year
Penetrance of mutations from leptin melanocortin pathway
Evaluation of the penetrance of mutation from leptin melanocortin pathway, that is to say the percentage of obesity in mutation carrier
Measured: 1 year
effect of age, sex, country of birth on mutations' penetrance.
Evaluation of the effect of age, sex, country of birth on mutations' penetrance.
Measured: 1 year
Clinical characteristics of children with severe obesity followed in CHRU of Nancy
Description of Clinical characteristics of children with severe obesity followed in CHRU of Nancy : weight in kg Description of the clinical characteristics :
Measured: 1 year
Clinical characteristics of children with severe obesity followed in CHRU of Nancy
Description of the clinical characteristics :BMI in kg/m²
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RENARD Emeline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938335
- Sponsor's protocol ID
- 2023PI
- Acronym
- OBEGEN
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Sequencing of a Large Panel of Genes From Leptin Melanocortin Pathway in Children Suffering From Severe Obesity
- ClinicalTrials.gov ID
- NCT05938335
- Acronym / sponsor ID
- OBEGEN / 2023PI
- Conditions
- Obesity, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 10 Jul 2023 (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.
About 380 million children and adolescents suffer from overweight and obesity at the global level. Obesity results from the interplay between biological (sex, age, fetal programming, gut microbiota, epigenetics, and genetics) and environmental factors (e.g., unhealthy diet, physical inactivity, stress). Mutations in genes from leptin melanocortin pathway are involved in "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. Exact frequencies of mutation in these genes are not precisely evaluated in french children with severe obesity. Moreover new treatment, such seltmelanotide are avalaible in case of certain mutation, leading to a significative weight loss in treated patients.
Detailed description
Obesity is a global health concern that affected more than 650 million adult people and more than 380 million children and adolescents worldwide, with no signs of slowing down despite major investments in health policy. Obestiy is a multifactorial disease, but 40 to 75% of body mass index (BMI) variation is explained by genetic factors.
Mutations in genes from leptin melanocortin pathway lead to "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. This pathway plays a central role in regulating mammalian food intake, energy expenditure and body weight regulation. Somes genes are well characterized such LEP gene, LEPR gene, or MC4R but others have been recently described as ADCY3, SIM1, SH2B1, NTRK2, BDNF, KSR2.
The frequency of these mutations are not precisely estimated in a group of french children with severe obesity.
Moreover, a precocious identification of these mutations, could afford, in certain case the possibility of a efficient treatment with setmelanotide, leading to a significant weight loss in treated patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe obese children | Experimental | Genetic: sequencing of a panel of 14 genes in leptin melanocortin pathwaychildren with severe obesity with BMI > 3sds |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- severe obesity with BMI > 3SDS
Key exclusion criteria (5 listed)
- genetic obesity (Prader Willi syndrome, Bardet Biedl syndrome, X fragile syndrome, Alstrom syndrome)
- BMI < 3 SDS
- age < 6 months
- monogenic non syndromic obesity, with mutation in genes of leptin melanocortin pathway previously diagnosed
- cushing syndrome
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 |
|---|---|---|
| sequencing of a panel of 14 genes in leptin melanocortin pathwaysequencing (NGS) of a panel of 14 genes in leptin melanocortin pathway in french children with severe obesity | Genetic | severe obese children |
Primary outcome
frequency of mutations of genes from leptin melanocortin pathway
Time frame: 1 year
Evaluating of the frequency of mutations of 14 genes from leptin melanocortin pathway (LEP, LEPR, POMC, PCSK1, MC3R, MC4R, MRAP2, ADCY3, SIM1, SH2B1, NTRK2, BDNF, KSR2) in a group of french children with severe obesity.
12 secondary outcomes
Clinical characteristics of children with severe obesity followed in CHRU of Nancy
Time frame: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Time frame: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Time frame: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Time frame: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Time frame: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Time frame: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Time frame: 1 year
Clinical characteristics of children with mutations of leptin melanocortin pathway
Time frame: 1 year
Penetrance of mutations from leptin melanocortin pathway
Time frame: 1 year
effect of age, sex, country of birth on mutations' penetrance.
Time frame: 1 year
Clinical characteristics of children with severe obesity followed in CHRU of Nancy
Time frame: 1 year
Clinical characteristics of children with severe obesity followed in CHRU of Nancy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity, Child
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
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
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.
Questions about this trial
What is this clinical trial studying?
A study testing sequencing of a panel of 14 genes in leptin melanocortin pathway in people with Obesity, Child, run by Central Hospital, Nancy, 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 1 inclusion and 5 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 10 Jul 2023. 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 Emeline RENARD (+33383154500, e.renard@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of mutations of genes from leptin melanocortin pathway (time frame: 1 year). 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 10 Jul 2023.