Menu
Recruiting NCT07296900

International Genetic Obesity Registry

Observational Genetic Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Genetic Obesity. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Change of somatic comorbidities under standard treatment [Time frame: every 5 years for 50 years]
  • Change of somatic comorbidities under standard treatment [Time frame: every 5 years for 50 years]
Secondary outcome measures (3)
  • genotype-phenotype correlation [Time frame: every 5 years for 50 years]
  • Age at onset for comorbidities [Time frame: every 5 years for 50 years]
  • Age at death [Time frame: at year 20 after study start]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Ulm University Clinic — Ulm

Identifiers

NCT: NCT07296900 · iGO Registry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗