International Genetic Obesity Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Change of somatic comorbidities under standard treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Not capable of understanding the aims of the protocol and to provide informed consent
结局指标
主要结局
Change of somatic comorbidities under standard treatment
时间窗: every 5 years for 50 years
Number of participants with abnormal laboratory test results. Laboratory measurements include. HbA1c \[%\], blood lipids \[mmol/l\], insulin \[mU/l\], glucose \[mg/dl\]
次要结局
- Age at onset for comorbidities(every 5 years for 50 years)
- genotype-phenotype correlation(every 5 years for 50 years)
- Age at death(at year 20 after study start)
研究者
Julia von Schnurbein
PD Dr. med.
University of Ulm