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

Sponsor
Alexandra Miriam Kiess
Study ID
NCT07716488
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • blood test, questionaire — OTHER
    blood test + questionaire

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Other: screening
    blood test, questionaire, clinical data

Primary Outcome Measure

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

Central Contacts

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