Early Genetic Identification of Obesity

Last updated: April 10, 2025
Sponsor: Rolfs Consulting und Verwaltungs-GmbH (RCV)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Learning Disorders

Diabetes Prevention

Vision Loss

Treatment

Genetic testing via blood collection

Clinical Study ID

NCT06239064
WEGIO 01-2023
  • Ages > 2
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 ageof 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 6years

  • The participant has rod/cone dystrophy

  • The participant is 2 or more years of age, is clinically diagnosed withBardet-Biedl-Syndrome (BBS) or is a sibling of an individual diagnosed with BBS viathe WEGIO study

Exclusion

Exclusion criteria:

  • Not fulfilling the inclusion criteria

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Genetic testing via blood collection
Phase:
Study Start date:
January 24, 2024
Estimated Completion Date:
March 01, 2027

Study 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

Connect with a study center

  • University of Rostock

    Rostock, Mecklenburg-Vorpommern 18055
    Germany

    Site Not Available

  • Universitätsklinikum Aachen (RWTH)

    Aachen, 52074
    Germany

    Active - Recruiting

  • KJF Klinik Josefinum

    Augsburg, 86154
    Germany

    Active - Recruiting

  • Universitätsklinikum Augsburg - Klinik für Kinder- und Jugendmedizin

    Augsburg, 86156
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg

    Bad Krozingen, 79189
    Germany

    Active - Recruiting

  • Klinikum Bielefeld Mitte

    Bielefeld, 33604
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn

    Bonn, 53127
    Germany

    Active - Recruiting

  • Praxis für Endokrinologie Dr. Daniel Pfaff

    Bückeburg, 31675
    Germany

    Active - Recruiting

  • Universitätsmedizin Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Klinikum Frankfurt (Oder)

    Frankfurt (Oder), 15236
    Germany

    Active - Recruiting

  • SRH Wald-Klinikum Gera

    Gera, 07548
    Germany

    Active - Recruiting

  • Universitätsmedizin Greifswald - Klinik und Poliklinik für Innere Medizin A

    Greifswald, 17475
    Germany

    Active - Recruiting

  • WolfartKlinik

    Gräfelfing, 82166
    Germany

    Active - Recruiting

  • Universitätsmedizin Göttingen - Klinik für Kinder- und Jugendmedizin

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Katholisches Kinderkrankenhaus WILHELMSTIFT

    Hamburg, 22149
    Germany

    Active - Recruiting

  • Kinder- und Jugendkrankenhaus Auf der Bult

    Hannover, 30173
    Germany

    Active - Recruiting

  • Hormonzentrum Heidelberg

    Heidelberg, 69115
    Germany

    Active - Recruiting

  • Kinder- und Jugendarztpraxis Nebras Mohammad

    Iserlohn, 58636
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena

    Jena, 07747
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Cellitinnen-Krankenkaus St. Franziskus

    Köln, 50825
    Germany

    Active - Recruiting

  • Sozialpädiatrisches Zentrum Leipzig

    Leipzig, 04129
    Germany

    Active - Recruiting

  • Universitätsmedizin Mannheim - Augenklinik

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Universitätsmedizin Mannheim/Augenklinik / Department of Ophthalmology

    Mannheim,
    Germany

    Active - Recruiting

  • Städtische Kliniken Mönchengladbach - Elisabeth-Krankenhaus Rheydt

    Mönchengladbach, 41239
    Germany

    Active - Recruiting

  • Kinder- und Jugendarztpraxis Sulaiman Al Sawaf

    Nettetal, 41334
    Germany

    Active - Recruiting

  • Dietrich-Bonhoeffer-Klinikum

    Neubrandenburg, 17036
    Germany

    Active - Recruiting

  • Hausarztpraxis Rahman & Detho

    Obertshausen, 63179
    Germany

    Active - Recruiting

  • Sana Klinikum Offenbach

    Offenbach am Main, 63069
    Germany

    Active - Recruiting

  • Kinderärzte am Leo

    Pforzheim, 75172
    Germany

    Active - Recruiting

  • Elblandklinikum Riesa

    Riesa, 01589
    Germany

    Active - Recruiting

  • GPR Klinikum Rüsselsheim

    Rüsselsheim, 65428
    Germany

    Active - Recruiting

  • Kinder- und Jugendpraxis Dogan

    Stuttgart, 70178
    Germany

    Active - Recruiting

  • SRH Zentralklinikum Suhl GmbH

    Suhl, 98527
    Germany

    Active - Recruiting

  • Praxis für Kinder- und Jugendmedizin Dr. med. Tabea Tippelt

    Velbert, 42551
    Germany

    Active - Recruiting

  • Dreifaltigkeits-Krankenhaus Wesseling

    Wesseling, 50389
    Germany

    Active - Recruiting

  • Praxis für Kinder- und Jugendmedizin Seyfullah Gökce

    Wiesbaden, 65185
    Germany

    Active - Recruiting

  • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik I

    Würzburg, 97080
    Germany

    Active - Recruiting

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