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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07716488
Acronym
FAMELIPIDCHILD
Enrollment
600
Registered
2026-07-21
Start date
2026-08-01
Completion date
2027-04-30
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease in Adolescents, Celiac Disease in Children, Congenital Heart Disease, Inflammatory Bowel Disease (IBD), Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors, Rheumatic Diseases

Keywords

lipid metabolism disorders, chronic disease, children, adolescents

Brief 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.

Interventions

OTHERblood test, questionaire

blood test + questionaire

Sponsors

Alexandra Miriam Kiess
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Prevalence of elevated lipid levels and familial hyperlipidemias in our sample of chronically ill children and adolescents6-12 months

Secondary

MeasureTime frame
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 homocysteine6-12 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
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 cohort6-12 months

Countries

Germany

Contacts

CONTACTAlexandra M Kiess, MD
AlexandraMiriam.Kiess@med.uni-jena.de0049-3641-9329578
PRINCIPAL_INVESTIGATORAlexandra M Kiess, MD

University Hospital Jena

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026