Early Genetic Identification of Obesity

Cognitive Impairment Clinical Trial

— WEGIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239064
• Other study ID #: WEGIO 01-2023
• Status: Recruiting
• Start date: January 24, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: June 2024
• Source: Rolfs Consulting und Verwaltungs-GmbH (RCV)
• Contact: Arndt Rolfs, PhD, MD
• Phone: +491708348540
• Email: arndt.rolfs[@]rcv-biotech.com
• Is FDA regulated: No
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2026
• Gender: All
• Age group: 2 Years and older

Eligibility

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:

• Not fulfilling the inclusion criteria

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Genetic testing via blood collection
blood collection

Locations

Country	Name	City	State
Germany	KJF Klinik Josefinum	Augsburg
Germany	Universitätsklinikum Augsburg - Klinik für Kinder- und Jugendmedizin	Augsburg
Germany	Klinikum Frankfurt (Oder)	Frankfurt (Oder)
Germany	WolfartKlinik	Gräfelfing
Germany	Kinder- und Jugendkrankenhaus Auf der Bult	Hannover
Germany	Cellitinnen-Krankenkaus St. Franziskus	Köln
Germany	Sozialpädiatrisches Zentrum Leipzig	Leipzig
Germany	Universitätsmedizin Mannheim - Augenklinik	Mannheim
Germany	Elblandklinikum Riesa	Riesa
Germany	Kinder- und Jugendpraxis Dogan	Stuttgart
Germany	Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik I	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Rolfs Consulting und Verwaltungs-GmbH (RCV)	Rhythm Pharmaceuticals, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BBS prevalence	To investigate the prevalence of BBS in patients suspected to a genetic obesity	2 years
Secondary	Phenotypic and genetic characterization	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	2 years