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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Child Obesity; Hunger; Gene Abnormality

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Antje Körner, Prof.; Phone Number: +49 341 9726500; Email: antje.koerner@medizin.uni-leipzig.de
• Study Contact Backup: Name: Eric Göpel, PhD; Phone Number: +49 341 9720465; Email: eric.goepel@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • Children's Hospital University of Leipzig
      • Contact: Roland W Pfaeffle, Prof.; Phone Number: +49 341 9726330; Email: roland.pfaeffle@medizin.uni-leipzig.de
      • Contact: Antje Koerner, Prof.; Phone Number: +49 341 9726500; Email: antje.koerner@medizin.uni-leipzig.de
      • Sub-Investigator: Eric Göpel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cohort from the registry CrescNet (NCT03072537) , data collection of body height and body weight in childhood by primary care pediatricians in Germany

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statements about spatial distribution	ZIP-Code related, place of residence of the test subjects	2 years
Role of hyperphagia symptoms	method to identify the form of obestity	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modifying of screening algorithms	alert pediatricians to a monogenic form of obesity that may be present and treatable	2 Years

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Rhythm Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: INDICATOR Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No