Early Genetic Identification of Obesity

NCT06239064 | Active Not Recruiting

• 1 other identifier: WEGIO 01-2023
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 37

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

Conditions

Obesity, Childhood; Hyperphagia; Retinopathy; Syndactyly; Polydactyly; Cognitive Impairment; Bardet-Biedl Syndrome; POMC Deficiency

Keywords

Early onset obesity; Hyperphagia; Genetics; Bardet-Biedl Syndrome; LEPR; POMC; PCSK1

Outcome Measures

Primary Outcomes (1)

• BBS prevalence

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

  2 years

Secondary Outcomes (1)

• Phenotypic and genetic characterization

  2 years

Study Arms (1)

Participants suspected to genetic obesity

Participants suspected to genetic obesity

Diagnostic Test: Genetic testing via blood collection

Interventions

Genetic testing via blood collection DIAGNOSTIC_TEST

blood collection

Participants suspected to genetic obesity

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Rolfs Consulting und Verwaltungs-GmbH (RCV): lead
• Rhythm Pharmaceuticals, Inc.: collaborator

Study Sites (37)

Universitätsklinikum Aachen (RWTH)

Aachen, 52074, Germany

Location

KJF Klinik Josefinum

Augsburg, 86154, Germany

Location

Universitätsklinikum Augsburg - Klinik für Kinder- und Jugendmedizin

Augsburg, 86156, Germany

Location

Universitätsklinikum Freiburg

Bad Krozingen, 79189, Germany

Location

Klinikum Bielefeld Mitte

Bielefeld, 33604, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Praxis für Endokrinologie Dr. Daniel Pfaff

Bückeburg, 31675, Germany

Location

Cellitinnen-Krankenkaus St. Franziskus

Cologne, 50825, Germany

Location

Universitätsmedizin Essen

Essen, 45147, Germany

Location

Klinikum Frankfurt (Oder)

Frankfurt (Oder), 15236, Germany

Location

SRH Wald-Klinikum Gera

Gera, 07548, Germany

Location

Universitätsmedizin Göttingen - Klinik für Kinder- und Jugendmedizin

Göttingen, 37075, Germany

Location

WolfartKlinik

Gräfelfing, 82166, Germany

Location

Universitätsmedizin Greifswald - Klinik und Poliklinik für Innere Medizin A

Greifswald, 17475, Germany

Location

Katholisches Kinderkrankenhaus WILHELMSTIFT

Hamburg, 22149, Germany

Location

Kinder- und Jugendkrankenhaus Auf der Bult

Hanover, 30173, Germany

Location

Hormonzentrum Heidelberg

Heidelberg, 69115, Germany

Location

Kinder- und Jugendarztpraxis Nebras Mohammad

Iserlohn, 58636, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

Location

Sozialpädiatrisches Zentrum Leipzig

Leipzig, 04129, Germany

Location

Universitätsmedizin Mannheim - Augenklinik

Mannheim, 68167, Germany

Location

Städtische Kliniken Mönchengladbach - Elisabeth-Krankenhaus Rheydt

Mönchengladbach, 41239, Germany

Location

Kinder- und Jugendarztpraxis Sulaiman Al Sawaf

Nettetal, 41334, Germany

Location

Dietrich-Bonhoeffer-Klinikum

Neubrandenburg, 17036, Germany

Location

Hausarztpraxis Rahman & Detho

Obertshausen, 63179, Germany

Location

Sana Klinikum Offenbach

Offenbach, 63069, Germany

Location

Kinderärzte am Leo

Pforzheim, 75172, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, 14467, Germany

Location

Elblandklinikum Riesa

Riesa, 01589, Germany

Location

GPR Klinikum Rüsselsheim

Rüsselsheim am Main, 65428, Germany

Location

Kinder- und Jugendpraxis Dogan

Stuttgart, 70178, Germany

Location

SRH Zentralklinikum Suhl GmbH

Suhl, 98527, Germany

Location

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

Velbert, 42551, Germany

Location

Dreifaltigkeits-Krankenhaus Wesseling

Wesseling, 50389, Germany

Location

Praxis für Kinder- und Jugendmedizin Seyfullah Gökce

Wiesbaden, 65185, Germany

Location

Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik I

Würzburg, 97080, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Pediatric Obesity; Hyperphagia; Retinal Diseases; Syndactyly; Polydactyly; Cognitive Dysfunction; Bardet-Biedl Syndrome; Proopiomelanocortin Deficiency

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Eye Diseases; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Retinitis Pigmentosa; Eye Diseases, Hereditary; Ciliopathies; Abnormalities, Multiple; Genetic Diseases, Inborn

Study Officials

• Arndt Rolfs, PhD, MD

  Rolfs Consulting und Verwaltungs-GmbH (RCV)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: January 24, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (37)