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 (FAMELIPIDCHILD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatic Diseases; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Congenital Heart Disease; Inflammatory Bowel Disease (IBD); Celiac Disease in Children; Celiac Disease in Adolescents
• Intervention / Treatment: Other: blood test, questionaire

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra M Kiess, MD; Phone Number: 0049-3641-9329578; Email: AlexandraMiriam.Kiess@med.uni-jena.de

Study Locations

• Germany
  • Jena, Germany
    • Recruiting
    • University Hospital Jena
    • Contact: Alexandra Kiess, MD; Phone Number: 004936419329578; Email: AlexandraMiriam.Kiess@med.uni-jena.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: screening; blood test, questionaire, clinical data	Other: blood test, questionaire; blood test + questionaire

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time 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 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

Collaborators and Investigators

• Sponsor: Alexandra Miriam Kiess
• Investigators: Principal Investigator: Alexandra M Kiess, MD, University Hospital Jena

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: children; adolescents; chronic disease; lipid metabolism disorders
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Intestinal Diseases; Connective Tissue Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Heart Defects, Congenital; Inflammatory Bowel Diseases; Lipid Metabolism Disorders; Rheumatic Diseases; Chronic Disease; Lipid Metabolism, Inborn Errors; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: 2026-4281-BO-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No