## Protocol Section
### Identification Module
**NCT ID:** NCT06420622

**Acronym:** INDICATOR

**Brief Title:** INDIcators for Clarifying the bAckground of exTreme Obesity in childRen

**Official Title:** INDIcators for Clarifying the bAckground of exTreme Obesity in childRen (INDICATOR)

#### Organization Study ID Info
**ID:** INDICATOR Study
#### Organization
**Class:** OTHER
**Full Name:** University of Leipzig
### Status Module
#### Completion Date
**Date:** 2026-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Rhythm Pharmaceuticals, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Leipzig

#### Responsible Party

**Investigator Affiliation:** University of Leipzig

**Investigator Full Name:** Antje Koerner, Prof. Dr. med.

**Investigator Title:** Prof. Dr. med.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Gene Abnormality

- Child Obesity

- Hunger

### Design Module

#### Bio Spec

**Description:** Saliva samples, Whole Exom Sequencing

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Other Outcomes

**Description:** alert pediatricians to a monogenic form of obesity that may be present and treatable

**Measure:** Modifying of screening algorithms

**Time Frame:** 2 Years

#### Primary Outcomes

**Description:** trait among children with early onset severe obesity

**Measure:** Prevalence of each monogenetic obesity

**Time Frame:** 2 years

**Description:** distinguish monogenetic obesity from classical polygenetic forms

**Measure:** Typical patterns of weight gain for each form of obesity

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** ZIP-Code related, place of residence of the test subjects

**Measure:** Statements about spatial distribution

**Time Frame:** 2 years

**Description:** method to identify the form of obestity

**Measure:** Role of hyperphagia symptoms

**Time Frame:** 2 years

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Minimum Age:** 2 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** antje.koerner@medizin.uni-leipzig.de

**Name:** Antje Körner, Prof.

**Phone:** +49 341 9726500

**Role:** CONTACT

**Contact 2:**

**Email:** eric.goepel@medizin.uni-leipzig.de

**Name:** Eric Göpel, PhD

**Phone:** +49 341 9720465

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Leipzig

**Contacts:**

***Contact 1:***

- **Email:** roland.pfaeffle@medizin.uni-leipzig.de

- **Name:** Roland W Pfaeffle, Prof.

- **Phone:** +49 341 9726330

- **Role:** CONTACT

***Contact 2:***

- **Email:** antje.koerner@medizin.uni-leipzig.de

- **Name:** Antje Koerner, Prof.

- **Phone:** +49 341 9726500

- **Role:** CONTACT

***Contact 3:***

- **Name:** Eric Göpel, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Germany

**Facility:** Children's Hospital University of Leipzig

**State:** Saxony

**Status:** RECRUITING

**Zip:** 04103

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M30155

- Name: Pediatric Obesity

- Relevance: HIGH

- As Found: Child Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

- ID: D000063766

- Term: Pediatric Obesity

### Misc Info Module

- Version Holder: 2024-05-31
