INDIcators for Clarifying the bAckground of exTreme Obesity in childRen
INDICATOR
1 other identifier
observational
1,000
1 country
1
Brief Summary
The study investigates the genetic backgrounds of extreme childhood obesity (using saliva sample) and contains short online questionnaires on family history, phenotypical characteristics and hunger behavior. It is an observational study in a predefined cohort (subjects with data in CrescNet aged 0-18 with BMI measurement(s) above the 99.5th percentile). Recruitment will initially be from CrescNet data through the cooperating pediatric and adolescent medical institutions associated with these initiative of data collection in Germany.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2024
CompletedFirst Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMay 20, 2024
May 1, 2024
1.5 years
May 14, 2024
May 14, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Prevalence of each monogenetic obesity
trait among children with early onset severe obesity
2 years
Typical patterns of weight gain for each form of obesity
distinguish monogenetic obesity from classical polygenetic forms
2 years
Secondary Outcomes (2)
Statements about spatial distribution
2 years
Role of hyperphagia symptoms
2 years
Other Outcomes (1)
Modifying of screening algorithms
2 Years
Eligibility Criteria
Cohort from the registry CrescNet (NCT03072537) , data collection of body height and body weight in childhood by primary care pediatricians in Germany
You may qualify if:
- 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
You may not qualify if:
- Known cause of servere early obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leipziglead
- Rhythm Pharmaceuticals, Inc.collaborator
Study Sites (1)
Children's Hospital University of Leipzig
Leipzig, Saxony, 04103, Germany
Biospecimen
Saliva samples, Whole Exom Sequencing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 20, 2024
Study Start
April 15, 2024
Primary Completion
October 31, 2025
Study Completion
March 31, 2026
Last Updated
May 20, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share