International Genetic Obesity Registry
ConditionGenetic Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Ulm
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Not capable of understanding the aims of the protocol and to provide informed consent
Trial population
Multi-Center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 \[bpm\].
Time frame
every 5 years for 50 years2
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 \[mg/dl\]
Time frame
every 5 years for 50 yearsSecondary outcomes
1
genotype-phenotype correlation
molecular genetic results will be compared to results from standardized physical examination, laboratory and instrument based tests
Time frame
every 5 years for 50 years2
Age at onset for comorbidities
comorbidities will be assessed via standard physical examination, laboratory and instrument based tests
Time frame
every 5 years for 50 years3
Age at death
patients are followed regulary, age at death (years) will be documented
Time frame
at year 20 after study startSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov