NCT06239064

Early Genetic Identification of Obesity

Whole Genetic Approach in Early Genetic Identification of Obesity (WEGIO)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Rolfs Consulting und Verwaltungs-GmbH (RCV) · Network
• Sex: All
• Age: 2 Years
• Healthy volunteers: —

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

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Genetic testing via blood collection	blood collection

Timeline

• Start date: 2024-01-24
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2024-02-02
• Last updated: 2025-09-29

Locations

37 sites across 1 country: Germany