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INDIcators for Clarifying the bAckground of exTreme Obesity in childRen

INDIcators for Clarifying the bAckground of exTreme Obesity in childRen (INDICATOR)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06420622
Acronym
INDICATOR
Enrollment
1000
Registered
2024-05-20
Start date
2024-04-15
Completion date
2026-03-31
Last updated
2024-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Obesity, Gene Abnormality, Hunger

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.

Detailed description

In order to be able to investigate the genetic background of extreme obesity, current BMI developments above the 99.5 BMI percentile (extreme obesity) are selected in the existing CrescNet register. Pediatricians (submitting the data) will be informed about these cases. They will be ask to re-identify the patient using the pseudonym (CrescNet-ID) maintained in the registry and to contact the family with a request to participate in the study. The study physician of the study center at the Leipzig University Hospital will take over the study inclusion as well as all necessary clarifications and consents for the study and the genetic examination contained therein. Since the potential probands may live anywhere in Germany, telemedical contact between the study center and the family (interested in participation) will be used. In addition to the above-mentioned study inclusion, the study physician is also responsible for instructing the family on the correct drawing, collection and sending of saliva samples to the study center, as well as instructing them on how to complete the hyperphagia questionnaire. At this appointment, the proband is assigned an internal study identification number (INDICATOR-ID). Saliva sample and all questionnaires are assigned to this number.

Interventions

None listed

Sponsors

Rhythm Pharmaceuticals, Inc.
CollaboratorINDUSTRY
University of Leipzig
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of each monogenetic obesity2 yearstrait among children with early onset severe obesity
Typical patterns of weight gain for each form of obesity2 yearsdistinguish monogenetic obesity from classical polygenetic forms

Secondary

MeasureTime frameDescription
Statements about spatial distribution2 yearsZIP-Code related, place of residence of the test subjects
Role of hyperphagia symptoms2 yearsmethod to identify the form of obestity

Other

MeasureTime frameDescription
Modifying of screening algorithms2 Yearsalert pediatricians to a monogenic form of obesity that may be present and treatable

Countries

Germany

Contacts

Primary ContactAntje Körner, Prof.
antje.koerner@medizin.uni-leipzig.de+49 341 9726500
Backup ContactEric Göpel, PhD
eric.goepel@medizin.uni-leipzig.de+49 341 9720465

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026