Investigating genetic factors in extreme childhood obesity
INDIcators for Clarifying the bAckground of exTreme Obesity in childRen (INDICATOR)
This study is trying to see how genetics might play a role in extreme obesity in children by looking at saliva samples and family history from kids aged 0-18 who are significantly overweight.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 1 site (Leipzig, Saxony) |
| Trial ID | NCT06420622 on ClinicalTrials.gov |
What this trial studies
This observational study explores the genetic backgrounds of extreme obesity in children by analyzing saliva samples and collecting data through online questionnaires regarding family history, phenotypical characteristics, and hunger behaviors. It targets children aged 0-18 with BMI measurements above the 99.5th percentile, utilizing existing data from the CrescNet registry. Pediatricians will identify eligible patients and facilitate telemedical consultations for informed consent and sample collection, ensuring a streamlined process for participation across Germany.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-18 with extreme obesity, defined as having a BMI above the 99.5th percentile.
Not a fit: Patients with known causes of severe early obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of the genetic factors contributing to extreme childhood obesity, potentially informing future treatments and interventions.
How similar studies have performed: While this approach is observational and builds on existing data, similar studies investigating genetic factors in obesity have shown promise in understanding the condition.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Test subjects older 5 years: BMI SDS between 0-5 years \> 1.881 (= p97) BMI SDS between 5 and 18 \>2.567 (=p99.5) Parents and subjects agree that the study information will be provided during a telemedical consultation by the study physician Exclusion Criteria: * Known cause of servere early obesity
Where this trial is running
Leipzig, Saxony
- Children's Hospital University of Leipzig — Leipzig, Saxony, Germany (Recruiting)
Study contacts
- Study coordinator: Antje Körner, Prof.
- Email: antje.koerner@medizin.uni-leipzig.de
- Phone: +49 341 9726500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.