Screening for Disorders of Lipid Metabolism and Familial Hyperlipidemia in Children and Adolescents With Increased Cardiovascular Risk Due to Chronic Diseases Such as Congenital Heart Disease, Chronic Inflammatory Bowel Disease, Celiac Disease and Rheumatic Disorders
NCT07716488 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2026-07-21
Summary
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.
Conditions
- Lipid Metabolism Disorders
- Lipid Metabolism, Inborn Errors
- Congenital Heart Disease
- Inflammatory Bowel Disease (IBD)
- Rheumatic Diseases
- Celiac Disease in Children
- Celiac Disease in Adolescents
Interventions
- OTHER
-
blood test, questionaire
blood test + questionaire
Sponsors & Collaborators
-
Alexandra Miriam Kiess
lead OTHER
Principal Investigators
-
Alexandra M Kiess, MD · University Hospital Jena
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2027-01-31
- Completion
- 2027-04-30
Countries
- Germany
Study Locations
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