Early Genetic Identification of Obesity (WEGIO)

Rolfs Consulting und Verwaltungs-GmbH (RCV)

Status

Enrolling

Conditions

POMC Deficiency

Bardet-Biedl Syndrome

Retinopathy

Polydactyly

Cognitive Impairment

Obesity, Childhood

Syndactyly

Hyperphagia

Treatments

Diagnostic Test: Genetic testing via blood collection

Study type

Observational

Funder types

NETWORK

Industry

Identifiers

NCT06239064

WEGIO 01-2023

Details and patient eligibility

About

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

Full 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

Enrollment

1,000 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria