INDIcators for Clarifying the bAckground of exTreme Obesity in childRen

Child Obesity Clinical Trial

— INDICATOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420622
• Other study ID #: INDICATOR Study
• Status: Recruiting
• Start date: April 15, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: University of Leipzig
• Contact: Antje Körner, Prof.
• Phone: +49 341 9726500
• Email: antje.koerner[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Obesity
• Gene Abnormality
• Hunger
• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
Germany	Children's Hospital University of Leipzig	Leipzig	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Rhythm Pharmaceuticals, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modifying of screening algorithms	alert pediatricians to a monogenic form of obesity that may be present and treatable	2 Years
Primary	Prevalence of each monogenetic obesity	trait among children with early onset severe obesity	2 years
Primary	Typical patterns of weight gain for each form of obesity	distinguish monogenetic obesity from classical polygenetic forms	2 years
Secondary	Statements about spatial distribution	ZIP-Code related, place of residence of the test subjects	2 years
Secondary	Role of hyperphagia symptoms	method to identify the form of obestity	2 years