Clinical trial NCT06420622: INDIcators for Clarifying the bAckground of exTreme Obesity in childRen
Official title: INDIcators for Clarifying the bAckground of exTreme Obesity in childRen (INDICATOR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gene Abnormality
Child Obesity
Hunger
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Rhythm Pharmaceuticals, Inc.
First posted: 2024-05-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of each monogenetic obesity
timeFrame: 2 years
measure: Typical patterns of weight gain for each form of obesity
timeFrame: 2 years
Secondary outcomes:
measure: Statements about spatial distribution
timeFrame: 2 years
measure: Role of hyperphagia symptoms
timeFrame: 2 years
Other outcomes:
measure: Modifying of screening algorithms
timeFrame: 2 Years
Locations:
city: Leipzig
country: Germany
facility: Children's Hospital University of Leipzig
state: Saxony
Study officials:
References: