Early Genetic Identification of Obesity

Recruiting

• Conditions: Polydactyly; Bardet-Biedl Syndrome; Hyperphagia; Retinopathy; Cognitive Impairment; POMC Deficiency; Obesity, Childhood; Syndactyly

• Registration Number: NCT06239064
• Lead Sponsor: Rolfs Consulting und Verwaltungs-GmbH (RCV)

Brief Summary

TITLE: Whole genetic approach in Early Genetic Identification of Obesity (WEGIO)

DESIGN: Multicenter epidemiological study

STUDY POPULATION: Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS)

NUMBER OF PARTICIPANTS: 1000 for initial genetic sequencing and app. 40 for the follow-up documentation

COORDINATING INVESTIGATOR: Prof. Dr. Arndt Rolfs

Detailed Description

TITLE: Whole genetic approach in Early Genetic Identification of Obesity (WEGIO)

DESIGN: Multicenter epidemiological study

STUDY POPULATION: Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS)

NUMBER OF PARTICIPANTS: 1000 for initial genetic sequencing and app. 40 for the follow-up documentation

COORDINATING INVESTIGATOR: Prof. Dr. Arndt Rolfs

PARTICIPATING COUNTRY: Germany

TREATMENT: Not applicable

PRIMARY OBJECTIVE: To investigate the prevalence of BBS in an at-risk population

SECONDARY OBJECTIVES:

* To explore genotype-phenotype correlation

* To assess genotypes distribution in Germany and compare to other countries

* To identify new genes/variants

* To investigate clinical characteristics in individuals diagnosed with BBS

DURATION OF RECRUITMENT: 32 months - total

24 months the recruitment of 1000 subjects

27 months follow up visits

32 months close out of sites

INCLUSION CRITERIA:

* Informed consent is obtained from the participant/parent/legal guardian

* The participant is 2 years of age or older

For a participant between 2 and 18 years of age:

* The participant has and had a body weight more than 97th percentile before the age of 6

* The participant has one or more of the following symptoms:

rod/cone dystrophy, renal abnormalities, ataxia, syndactyly, polydactyly, brachydactyly, hyperphagia, cognitive impairment, speech delay, hypogonadism

For a participant who is 18 years of age or older:

* The participant has BMI ≥ 30 kg/m2

* The participant had a body weight more than 97th percentile before the age of 6 years

* The participant has rod/cone dystrophy

* The participant is 2 or more years of age, is clinically diagnosed with Bardet-Biedl-Syndrome (BBS) or is a sibling of an individual diagnosed with BBS via the WEGIO study

Study Timeline

• Study Start: 2024-01-24
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BBS prevalence	2 years	To investigate the prevalence of BBS in patients suspected to a genetic obesity

Secondary Outcome Measures

Name	Time	Method
Phenotypic and genetic characterization	2 years	To understand the genotype-phenotype correlation; to assess genotypes distribution in Germany and compare to other countries; to identify new genes/variants; to investigate clinical characteristics in individuals diagnosed with BBS

Trial Locations

Locations (37)

Universitätsklinikum Aachen (RWTH); 🇩🇪 Aachen, Germany

KJF Klinik Josefinum; 🇩🇪 Augsburg, Germany

Universitätsklinikum Augsburg - Klinik für Kinder- und Jugendmedizin; 🇩🇪 Augsburg, Germany

Universitätsklinikum Freiburg; 🇩🇪 Bad Krozingen, Germany

Klinikum Bielefeld Mitte; 🇩🇪 Bielefeld, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Praxis für Endokrinologie Dr. Daniel Pfaff; 🇩🇪 Bückeburg, Germany

Universitätsmedizin Essen; 🇩🇪 Essen, Germany

Klinikum Frankfurt (Oder); 🇩🇪 Frankfurt (Oder), Germany

SRH Wald-Klinikum Gera; 🇩🇪 Gera, Germany

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