Childhood ObesityPeLiNCT02645422
Genetic Determinants and Clinical Consequences of Early-onset Severe Obesity
An observational study of Childhood Obesity, run by Helsinki University Central Hospital.
Trial summary
The aim of the present study is to identify new obesity-related genetic defects and determine their association with clinical manifestations in families with childhood-onset severe obesity. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Childhood Obesity
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 31 Dec 2023
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study subjects include children and adolescent with severe, early-onset childhood obesity. Early-onset obesity is defined as height-adjusted weight >60 % (corresponding to severe obesity) before the age of 7 years.
Who may be able to join
- children and adolescents age 10-18 years
- height-adjusted weight >60 % before the age of 7 years.
- Finnish descent
Who cannot join
- patients with a known endocrine or genetic disorder underlying obesity (e.g. Prader-Willi syndrome, hypercortisolism, hypothyroidism)
About this study
The aim of the present study is to identify new obesity-related genetic defects and determine their association with clinical manifestations in families with childhood-onset severe obesity. The investigators hypothesize that by exploring children with severe early-onset obesity they can find new obesity-related genetic defects and by exploring obesity-associated clinical manifestations the investigators can elucidate the outcomes of severe childhood obesity.
Read the detailed description
Obesity is a complex disorder with many contributing genetic and environmental factors. The genetic causes and mechanisms for severe childhood obesity are still incompletely understood. It is acknowledged that obesity in some individuals could be a consequence of rare genetic variants with strong effect - these rare variants might be population specific.
The aims of this study are to determine
- inheritance patterns of early-onset obesity
- new obesity-related genetic variants and disease-causing gene mutations
- the association between obesity-related genetic defects and clinical manifestations
- the association between obesity-related genetic defects and psychiatric symptoms in patients with early-onset obesity and their first-degree relatives
Significant advancements in genetic methodology provide new tools to explore genetic defects underlying obesity. Family-based approach provides several advantages compared to cohort studies to investigate genetic determinants of complex diseases.The unique genetic composition of the Finnish population enables identification of novel genetic entities.
Discovery of genetic defects associated with severe childhood-onset obesity will increase the investigators understanding of the pathogenesis of obesity and allows early detection, by genetic testing, of those at increased risk and optimal targeting of preventive measures.
- Conditions
- Childhood Obesity
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with gene mutations or genetic variants in children with early-onset severe obesity
Measured: Baseline, first day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startDec 2015
- Primary completion22 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Folkhälsan Researech Center, Karolinska Institutet
- Responsible party
- Principal investigator, Petra Loid, Helsinki University Central Hospital
- Investigators
- Outi Mäkitie, Prof., Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645422
- Sponsor's protocol ID
- HUCH43/2015
- Acronym
- PeLi
- Status last verified
- Sep 2023
- First submitted
- 9 Dec 2015
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Determinants and Clinical Consequences of Early-onset Severe Obesity
- ClinicalTrials.gov ID
- NCT02645422
- Acronym / sponsor ID
- PeLi / HUCH43/2015
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Folkhälsan Researech Center, Karolinska Institutet
- Study start
- Dec 2015 (actual)
- Primary completion
- 22 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- 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 aim of the present study is to identify new obesity-related genetic defects and determine their association with clinical manifestations in families with childhood-onset severe obesity. The investigators hypothesize that by exploring children with severe early-onset obesity they can find new obesity-related genetic defects and by exploring obesity-associated clinical manifestations the investigators can elucidate the outcomes of severe childhood obesity.
Detailed description
Obesity is a complex disorder with many contributing genetic and environmental factors. The genetic causes and mechanisms for severe childhood obesity are still incompletely understood. It is acknowledged that obesity in some individuals could be a consequence of rare genetic variants with strong effect - these rare variants might be population specific.
The aims of this study are to determine
- inheritance patterns of early-onset obesity
- new obesity-related genetic variants and disease-causing gene mutations
- the association between obesity-related genetic defects and clinical manifestations
- the association between obesity-related genetic defects and psychiatric symptoms in patients with early-onset obesity and their first-degree relatives
Significant advancements in genetic methodology provide new tools to explore genetic defects underlying obesity. Family-based approach provides several advantages compared to cohort studies to investigate genetic determinants of complex diseases.The unique genetic composition of the Finnish population enables identification of novel genetic entities.
Discovery of genetic defects associated with severe childhood-onset obesity will increase the investigators understanding of the pathogenesis of obesity and allows early detection, by genetic testing, of those at increased risk and optimal targeting of preventive measures.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study subjects include children and adolescent with severe, early-onset childhood obesity. Early-onset obesity is defined as height-adjusted weight >60 % (corresponding to severe obesity) before the age of 7 years.
Key inclusion criteria (3 listed)
- children and adolescents age 10-18 years
- height-adjusted weight >60 % before the age of 7 years.
- Finnish descent
Key exclusion criteria (1 listed)
- patients with a known endocrine or genetic disorder underlying obesity (e.g. Prader-Willi syndrome, hypercortisolism, hypothyroidism)
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
Number of patients with gene mutations or genetic variants in children with early-onset severe obesity
Time frame: Baseline, first day of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- 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.
Outi Mäkitie, Prof. study director
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Helsinki University Central Hospital.
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 3 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 22 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with gene mutations or genetic variants in children with early-onset severe obesity (time frame: Baseline, first day of enrollment). 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 22 Sep 2023.