International Genetic Obesity Registry

NCT07296900 | Recruiting

• 1 other identifier: iGO Registry
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Genetic obesity results from changes in specific genes that affect appetite regulation, metabolism, and fat storage. Its severity and associated health issues vary depending on the genetic cause. In some cases, hormonal imbalances, developmental delays, or other complications may also occur. Identifying the genetic cause is essential for personalized treatment and understanding potential symptoms. As genetic obesity is rare, specialists often encounter few patients with diverse genetic backgrounds and clinical features. Therefore, collecting global data is crucial to improve our understanding of the condition's progression, complications, and treatment responses for each genetic subtype. To support this, the International Genetic Obesity Registry (iGO Registry) has been established to gather detailed patient information on genetic obesity. This registry will help advance research and improve clinical care for affected individuals. It will collect data from routine outpatient visits, focusing on relevant diagnostic and treatment information on an international level.

Conditions

Genetic Obesity

Keywords

genetic obesity; patient registry; monogenic obesity; natural history

Outcome Measures

Primary Outcomes (2)

• Change of somatic comorbidities under standard treatment

  Number of participants with abnormal physical examination findings under standard treatment. Physical examinations include: Body weight \[kg\], body height \[cm\], blood pressure \[mmHg\], heart rate \[bpm\].

  every 5 years for 50 years

• Change of somatic comorbidities under standard treatment

  Number of participants with abnormal laboratory test results. Laboratory measurements include. HbA1c \[%\], blood lipids \[mmol/l\], insulin \[mU/l\], glucose \[mg/dl\]

  every 5 years for 50 years

Secondary Outcomes (3)

• genotype-phenotype correlation

  every 5 years for 50 years

• Age at onset for comorbidities

  every 5 years for 50 years

• Age at death

  at year 20 after study start

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multi-Center

You may qualify if:

• Patients with
• genetically confirmed genetic obesity (ACMG classification 3-5, associated with obesity) and/or
• early onset severe obesity (BMI ≥ 120% 95th percentile or ≥ 35 kg/m2 before 5 years of age) if genetic testing was performed
• Capable of understanding the aims of the protocol and to provide informed consent (for children and chronically incapacitated individuals, consent is given by their legal guardians)

You may not qualify if:

• Not capable of understanding the aims of the protocol and to provide informed consent

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Ulm University Clinic

Ulm, Germany

RECRUITING

Central Study Contacts

Julia von Schnurbein, PD Dr.

CONTACT

0049 731 500 57401; julia.vonschnurbein@uniklinik-ulm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 22, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): November 1, 2075
• Study Completion (Estimated): November 1, 2075
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)