Lipid Metabolism DisordersFAMELIPIDCHILDNCT07716488
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
A study testing blood test, questionaire in people with Lipid Metabolism Disorders and Lipid Metabolism, Inborn Errors, run by Alexandra Miriam Kiess at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors, Congenital Heart Disease
- What is being tested?
- blood test, questionaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Jena
Jena
Alexandra Kiess, MD, 004936419329578, AlexandraMiriam.Kiess@med.uni-jena.de
About this study
Official title: 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.
- Conditions
- Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors, Congenital Heart Disease, Inflammatory Bowel Disease (IBD), Rheumatic Diseases, Celiac Disease in Children
- Being tested
- blood test, questionaire
- Keywords
- lipid metabolism disorders, chronic disease, children, adolescents
- Medical subject headings
- Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors, Heart Defects, Congenital, Inflammatory Bowel Diseases, Rheumatic Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood test, questionaireOther
blood test + questionaire
| Study group | Role | What they receive |
|---|---|---|
| screening | Other | blood test, questionaire, clinical data Receives: Other: blood test, questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of elevated lipid levels and familial hyperlipidemias in our sample of chronically ill children and adolescents
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra Miriam Kiess
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexandra Miriam Kiess, Jena University Hospital
- Investigators
- Alexandra M Kiess, MD, Principal investigator, University Hospital Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716488
- Sponsor's protocol ID
- 2026-4281-BO-A
- Acronym
- FAMELIPIDCHILD
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07716488
- Acronym / sponsor ID
- FAMELIPIDCHILD / 2026-4281-BO-A
- Conditions
- Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors, Congenital Heart Disease, Inflammatory Bowel Disease (IBD), Rheumatic Diseases, Celiac Disease in Children
- Keywords
- lipid metabolism disorders, chronic disease, children, adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Alexandra Miriam KiessUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening | Other | Other: blood test, questionaireblood test, questionaire, clinical data |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood test, questionaireblood test + questionaire | Other | screening |
Primary outcome
Prevalence of elevated lipid levels and familial hyperlipidemias in our sample of chronically ill children and adolescents
Time frame: 6-12 months
4 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 6-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra M Kiess, MD principal investigator
University Hospital Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood test, questionaire in people with Lipid Metabolism Disorders and Lipid Metabolism, Inborn Errors, run by Alexandra Miriam Kiess at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra M Kiess, MD (0049-3641-9329578, AlexandraMiriam.Kiess@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.