Early Genetic Identification of Obesity
- Conditions
- PolydactylyBardet-Biedl SyndromeHyperphagiaRetinopathyCognitive ImpairmentPOMC DeficiencyObesity, ChildhoodSyndactyly
- Interventions
- Diagnostic Test: Genetic testing via blood collection
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants suspected to genetic obesity Genetic testing via blood collection Participants suspected to genetic obesity
- 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
Universitätsmedizin Greifswald - Klinik und Poliklinik für Innere Medizin A
🇩🇪Greifswald, Germany
WolfartKlinik
🇩🇪Gräfelfing, Germany
Universitätsmedizin Göttingen - Klinik für Kinder- und Jugendmedizin
🇩🇪Göttingen, Germany
Katholisches Kinderkrankenhaus WILHELMSTIFT
🇩🇪Hamburg, Germany
Kinder- und Jugendkrankenhaus Auf der Bult
🇩🇪Hannover, Germany
Hormonzentrum Heidelberg
🇩🇪Heidelberg, Germany
Kinder- und Jugendarztpraxis Nebras Mohammad
🇩🇪Iserlohn, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
🇩🇪Kiel, Germany
Cellitinnen-Krankenkaus St. Franziskus
🇩🇪Köln, Germany
Sozialpädiatrisches Zentrum Leipzig
🇩🇪Leipzig, Germany
Universitätsmedizin Mannheim - Augenklinik
🇩🇪Mannheim, Germany
Städtische Kliniken Mönchengladbach - Elisabeth-Krankenhaus Rheydt
🇩🇪Mönchengladbach, Germany
Kinder- und Jugendarztpraxis Sulaiman Al Sawaf
🇩🇪Nettetal, Germany
Dietrich-Bonhoeffer-Klinikum
🇩🇪Neubrandenburg, Germany
Hausarztpraxis Rahman & Detho
🇩🇪Obertshausen, Germany
Sana Klinikum Offenbach
🇩🇪Offenbach am Main, Germany
Kinderärzte am Leo
🇩🇪Pforzheim, Germany
Klinikum Ernst von Bergmann
🇩🇪Potsdam, Germany
Elblandklinikum Riesa
🇩🇪Riesa, Germany
GPR Klinikum Rüsselsheim
🇩🇪Rüsselsheim, Germany
Kinder- und Jugendpraxis Dogan
🇩🇪Stuttgart, Germany
SRH Zentralklinikum Suhl GmbH
🇩🇪Suhl, Germany
Praxis für Kinder- und Jugendmedizin Dr. med. Tabea Tippelt
🇩🇪Velbert, Germany
Dreifaltigkeits-Krankenhaus Wesseling
🇩🇪Wesseling, Germany
Praxis für Kinder- und Jugendmedizin Seyfullah Gökce
🇩🇪Wiesbaden, Germany
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik I
🇩🇪Würzburg, Germany