Early Genetic Identification of Obesity — WEGIO  

Cognitive Impairment Clinical Trial

Official title: Whole Genetic Approach in Early Genetic Identification of Obesity (WEGIO)

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT06239064
• Study type: Observational
• Source: Rolfs Consulting und Verwaltungs-GmbH (RCV)
• Contact: Arndt Rolfs, PhD, MD
• Phone: +491708348540
• Email: arndt.rolfs@rcv-biotech.com
• Status: Recruiting
• Start date: January 24, 2024
• Completion date: March 1, 2027