Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2024-01-24
2027-03-01
Brief Summary
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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
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants suspected to genetic obesity
Participants suspected to genetic obesity
Genetic testing via blood collection
blood collection
Interventions
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Genetic testing via blood collection
blood collection
Eligibility Criteria
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Inclusion Criteria
* 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
2 Years
ALL
No
Sponsors
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Rhythm Pharmaceuticals, Inc.
INDUSTRY
Rolfs Consulting und Verwaltungs-GmbH (RCV)
NETWORK
Responsible Party
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Principal Investigators
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Arndt Rolfs, PhD, MD
Role: STUDY_CHAIR
Rolfs Consulting und Verwaltungs-GmbH (RCV)
Locations
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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
Cellitinnen-Krankenkaus St. Franziskus
Cologne, , Germany
Universitätsmedizin Essen
Essen, , Germany
Klinikum Frankfurt (Oder)
Frankfurt (Oder), , Germany
SRH Wald-Klinikum Gera
Gera, , Germany
Universitätsmedizin Göttingen - Klinik für Kinder- und Jugendmedizin
Göttingen, , Germany
WolfartKlinik
Gräfelfing, , Germany
Universitätsmedizin Greifswald - Klinik und Poliklinik für Innere Medizin A
Greifswald, , Germany
Katholisches Kinderkrankenhaus WILHELMSTIFT
Hamburg, , Germany
Kinder- und Jugendkrankenhaus Auf der Bult
Hanover, , Germany
Hormonzentrum Heidelberg
Heidelberg, , Germany
Kinder- und Jugendarztpraxis Nebras Mohammad
Iserlohn, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , 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, , Germany
Kinderärzte am Leo
Pforzheim, , Germany
Klinikum Ernst von Bergmann
Potsdam, , Germany
Elblandklinikum Riesa
Riesa, , Germany
GPR Klinikum Rüsselsheim
Rüsselsheim am Main, , 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
Countries
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Other Identifiers
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WEGIO 01-2023
Identifier Type: -
Identifier Source: org_study_id
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