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 | Recruiting

• 1 other identifier: 2026-4281-BO-A
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lipid metabolism disorders; chronic disease; children; adolescents

Outcome Measures

Primary Outcomes (1)

• Prevalence of elevated lipid levels and familial hyperlipidemias in our sample of chronically ill children and adolescents

  6-12 months

Secondary Outcomes (4)

• 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

Study Arms (1)

screening

OTHER

blood test, questionaire, clinical data

Other: blood test, questionaire

Interventions

blood test, questionaire OTHER

blood test + questionaire

screening

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Alexandra Miriam Kiess: lead

Study Sites (1)

University Hospital Jena

Jena, Germany

RECRUITING

MeSH Terms

Conditions

Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Heart Defects, Congenital; Inflammatory Bowel Diseases; Rheumatic Diseases; Chronic Disease

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Alexandra M Kiess, MD

  University Hospital Jena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra M Kiess, MD

CONTACT

0049-3641-9329578; AlexandraMiriam.Kiess@med.uni-jena.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)