Childhood ObesityNCT04491344
Leipzig Childhood Obesity Study
An observational study of Childhood Obesity, run by University of Leipzig at 1 site in Germany.
Trial summary
The aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2002to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Overweight and obese children and adolescents
Who may be able to join
- all pediatric patients seen in the adiposity outpatient clinic
- informed patient consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research Leipzig
Leipzig, Saxony, 04103
Antje Körner, Prof, MD, +49 341 97-26500, Antje.Koerner@medizin.uni-leipzig.de
Julian Schwartze, +49 341 97-26537, JulianTristan.Schwartze@medizin.uni-leipzig.de
About this study
Official title: Extended Geno- and Phenotyping of Overweight and Obese Children and Adolescents
The aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity.
Read the detailed description
In order to identify single nucleotide polymorphisms blood and serum samples during oral glucose tolerance testing are routinely obtained from pediatric patients visiting the adiposity outpatient clinic.
- Conditions
- Childhood Obesity
- Keywords
- Single nucleotide polymorphisms, Obesity, Insulin resistance, Metabolic syndrome, Oral glucose tolerance test
- Medical subject headings
- Pediatric Obesity, Obesity, Insulin Resistance, Metabolic Syndrome
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 |
|---|---|---|
| Children with overweight and obesity | Overweight and obese children and adolescents visiting the adiposity outpatient clinic. | |
| adults | follow up of patients into adulthood | |
| control group | matched control group with children, adolescents and aduts without obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene-dependent association with phenotypical traits in overweight and obese children
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study startJan 2002
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (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.
- 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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antje Koerner, Prof. Dr. med., University of Leipzig
- Investigators
- Antje Körner, Prof, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491344
- Sponsor's protocol ID
- ADI cohort Leipzig
- Status last verified
- Nov 2023
- First submitted
- 24 Jul 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Geno- and Phenotyping of Overweight and Obese Children and Adolescents
- ClinicalTrials.gov ID
- NCT04491344
- Acronym / sponsor ID
- ADI cohort Leipzig
- Conditions
- Childhood Obesity
- Keywords
- Single nucleotide polymorphisms, Obesity, Insulin resistance, Metabolic syndrome, Oral glucose tolerance test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 29 Jul 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 aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity.
Detailed description
In order to identify single nucleotide polymorphisms blood and serum samples during oral glucose tolerance testing are routinely obtained from pediatric patients visiting the adiposity outpatient clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with overweight and obesity | – | –Overweight and obese children and adolescents visiting the adiposity outpatient clinic. |
| adults | – | –follow up of patients into adulthood |
| control group | – | –matched control group with children, adolescents and aduts without obesity |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Overweight and obese children and adolescents
Key inclusion criteria (2 listed)
- all pediatric patients seen in the adiposity outpatient clinic
- informed patient consent
Key exclusion criteria (1 listed)
- none
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
Gene-dependent association with phenotypical traits in overweight and obese children
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Link to the pediatric adiposity outpatient clinicLink provided by the sponsor.
- Link to Prof Antje Körner's GroupLink provided by the sponsor.
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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.
Antje Körner, Prof, MD principal investigator
University of Leipzig
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 Childhood Obesity, run by University of Leipzig at 1 site in Germany.
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 2 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: looking for participants now, as of the sponsor's last update on 7 Nov 2023. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antje Körner, Prof, MD (+49 341 97-26500, Antje.Koerner@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene-dependent association with phenotypical traits in overweight and obese children (time frame: 20 years). 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 7 Nov 2023.