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临床试验/NCT07716488
NCT07716488招募中不适用

Screening Auf Lipidstoffwechselstörungen Und familiäre Hyperlipidämien Bei Kindern Und Jugendlichen Mit erhöhtem kardiovaskulären Risiko Durch Chronische Erkrankungen Wie Angeborene Herzfehler, Chronisch entzündliche Darmerkrankungen, Zöliakie Sowie Rheumatische Erkrankungen

Alexandra Miriam Kiess1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Prevalence of elevated lipid levels and familial hyperlipidemias in our sample of chronically ill children and adolescents

研究概览

简要总结

Preventive measures are increasingly coming to the forefront of medicine. Many of these measures can be implemented as early as childhood and adolescence. For instance, the early detection and treatment of cardiovascular risk factors can significantly reduce long-term morbidity and mortality associated with cardiovascular diseases such as heart attack and stroke. For years, there has been discussion in Germany about assessing lipid profiles during childhood and adolescence to enable early intervention in cases of conditions like familial hypercholesterolemia. However, comprehensive screening has not yet been established in either clinical guidelines or routine practice. In other countries, such as Norway, universal screening has been conducted for many years and has already demonstrated both its benefits and cost-effectiveness. In Germany, screening, and subsequent early treatment if needed, is currently limited to a small number of children and adolescents-such as patients with type 1 diabetes mellitus (T1DM)-as part of their routine preventive check-ups. The prevalence of dyslipidemia in T1DM is approximately 15%. Reliable prevalence data are lacking for almost all other chronic conditions affecting children and adolescents (e.g., inflammatory bowel disease, celiac disease, rheumatic diseases, congenital heart defects). Through a pilot project at Jena University Hospital, we aim to screen children and adolescents with chronic conditions who are already at increased cardiovascular risk due to their underlying diseases. The project will record lipid levels, clinical data, family history, and lifestyle factors. The results of this study enable us, on the one hand, to help the individual through early diagnosis and consequent treatment recommendations; on the other hand, the data provide important information regarding the prevalence of hyperlipidemia and other risk factors-such as physical inactivity-within this high-risk cohort.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 5 to 18 years who are being treated at the UKJ in one of our specialized pediatric clinics for a chronic condition-such as a congenital heart defect, chronic inflammatory bowel disease, celiac disease, or a rheumatic disease.

排除标准

  • Lack of consent from the patient or legal guardian(s)

结局指标

主要结局

Prevalence of elevated lipid levels and familial hyperlipidemias in our sample of chronically ill children and adolescents

时间窗: 6-12 months

次要结局

  • Prevalence of unhealthy lifestyle (lack of physical activity, high media consumption, unhealthy eating habits) and familial predisposition regarding cardiovascular risk factors, and their correlation with the measured lipid levels, in our cohort(6-12 months)
  • Determination of the magnitude of elevations (mean and standard deviation [SD], and-where comparative data exist-age-appropriate percentiles) of: LDL cholesterol and lipoprotein(a), as well as total and HDL cholesterol, triglycerides, and homocysteine(6-12 months)
  • Correlation of the measured laboratory parameters with height, weight, BMI, comorbidities, medication, age, and sex, as well as lifestyle factors and family history.(6-12 months)
  • Investigation of whether the prevalence differs from that of the general population and from a further comparison group-patients treated at our center for type 1 diabetes mellitus, for whom this screening has been established for years.(6-12 months)

研究者

发起方
Alexandra Miriam Kiess
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alexandra Miriam Kiess

Principal investigator

Jena University Hospital

研究点 (1)

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