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 — Not applicable, Recruiting, 600 participants, Alexandra Miriam Kiess

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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

RegistryNCT07716488, acronym FAMELIPIDCHILD
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, screening
Enrollment600 (Estimated)
SponsorAlexandra Miriam Kiess (Other)
ConditionsLipid Metabolism Disorders, Lipid Metabolism, Inborn Errors, Congenital Heart Disease, Inflammatory Bowel Disease (IBD), Rheumatic Diseases, Celiac Disease in Children, Celiac Disease in Adolescents
Interventionsblood test, questionaire (Other)
Datesstart 2026-08-01 (estimated), primary completion 2027-01-31 (estimated), completion 2027-04-30 (estimated), first posted 2026-07-21, last updated 2026-07-21
Locations1 site in Germany

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All trials for Lipid Metabolism Disorders All trials for Lipid Metabolism, Inborn Errors All trials of blood test, questionaire

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
screeningOtherOther: blood test, questionaireblood test, questionaire, clinical data
  • blood test, questionaire (Other): blood test + questionaire

+Outcome measures

Primary outcomes

  • Prevalence of elevated lipid levels and familial hyperlipidemias in our sample of chronically ill children and adolescents [6-12 months]

Secondary outcomes

  • 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]
  • 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]

+Eligibility

Sex: All, ages: 6 Years to 18 Years

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)

+Locations (1)

FacilityCityCountryStatus
University Hospital JenaJenaGermanyRecruiting

+Investigators