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Obesity, ChildhoodWEGIONCT06239064

Early Genetic Identification of Obesity

An observational study of Obesity, Childhood and Hyperphagia, run by Rolfs Consulting und Verwaltungs-GmbH (RCV) at 37 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Obesity, Childhood, Hyperphagia, Retinopathy
What is being tested?
Genetic testing via blood collection
How many people
1,000 participants
Where
37 sitesGermany
Study dates
24 Jan 2024to 1 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • Child, Adult, Older adult

Study population: Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS)

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Not fulfilling the inclusion criteria

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Germany37 sites

  • Universitätsklinikum Aachen (RWTH)

    Aachen, 52074

  • KJF Klinik Josefinum

    Augsburg, 86154

  • Universitätsklinikum Augsburg - Klinik für Kinder- und Jugendmedizin

    Augsburg, 86156

  • Universitätsklinikum Freiburg

    Bad Krozingen, 79189

  • Klinikum Bielefeld Mitte

    Bielefeld, 33604

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Praxis für Endokrinologie Dr. Daniel Pfaff

    Bückeburg, 31675

  • Cellitinnen-Krankenkaus St. Franziskus

    Cologne, 50825

  • Universitätsmedizin Essen

    Essen, 45147

  • Klinikum Frankfurt (Oder)

    Frankfurt (Oder), 15236

  • SRH Wald-Klinikum Gera

    Gera, 07548

  • Universitätsmedizin Göttingen - Klinik für Kinder- und Jugendmedizin

    Göttingen, 37075

  • WolfartKlinik

    Gräfelfing, 82166

  • Universitätsmedizin Greifswald - Klinik und Poliklinik für Innere Medizin A

    Greifswald, 17475

  • Katholisches Kinderkrankenhaus WILHELMSTIFT

    Hamburg, 22149

  • Kinder- und Jugendkrankenhaus Auf der Bult

    Hanover, 30173

  • Hormonzentrum Heidelberg

    Heidelberg, 69115

  • Kinder- und Jugendarztpraxis Nebras Mohammad

    Iserlohn, 58636

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105

  • Sozialpädiatrisches Zentrum Leipzig

    Leipzig, 04129

  • Universitätsmedizin Mannheim - Augenklinik

    Mannheim, 68167

  • Städtische Kliniken Mönchengladbach - Elisabeth-Krankenhaus Rheydt

    Mönchengladbach, 41239

  • Kinder- und Jugendarztpraxis Sulaiman Al Sawaf

    Nettetal, 41334

  • Dietrich-Bonhoeffer-Klinikum

    Neubrandenburg, 17036

  • Hausarztpraxis Rahman & Detho

    Obertshausen, 63179

  • Sana Klinikum Offenbach

    Offenbach, 63069

  • Kinderärzte am Leo

    Pforzheim, 75172

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

  • Elblandklinikum Riesa

    Riesa, 01589

  • GPR Klinikum Rüsselsheim

    Rüsselsheim am Main, 65428

  • Kinder- und Jugendpraxis Dogan

    Stuttgart, 70178

  • SRH Zentralklinikum Suhl GmbH

    Suhl, 98527

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

    Velbert, 42551

  • Dreifaltigkeits-Krankenhaus Wesseling

    Wesseling, 50389

  • Praxis für Kinder- und Jugendmedizin Seyfullah Gökce

    Wiesbaden, 65185

  • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik I

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Whole Genetic Approach in Early Genetic Identification of Obesity (WEGIO)

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

Read the 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
Being tested
Genetic testing via blood collection
Keywords
Early onset obesity, Hyperphagia, Genetics, Bardet-Biedl Syndrome, LEPR, POMC, PCSK1
Medical subject headings
Pediatric Obesity, Hyperphagia, Retinal Diseases, Syndactyly, Polydactyly, Cognitive Dysfunction, Bardet-Biedl Syndrome, Proopiomelanocortin Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic testing via blood collectionDiagnostic test

    blood collection

Study groups in NCT06239064
Study groupRoleWhat they receive
Participants suspected to genetic obesityParticipants suspected to genetic obesity
Receives: Diagnostic Test: Genetic testing via blood collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BBS prevalence

    To investigate the prevalence of BBS in patients suspected to a genetic obesity

    Measured: 2 years

Secondary outcomes (1)

  1. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start24 Jan 2024
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06239064
Sponsor's protocol ID
WEGIO 01-2023
Acronym
WEGIO
Status last verified
Feb 2025
First submitted
25 Jan 2024
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Childhood and Hyperphagia, run by Rolfs Consulting und Verwaltungs-GmbH (RCV) at 37 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BBS prevalence (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06239064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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