Status:
RECRUITING
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
Lead Sponsor:
Gaia AG
Collaborating Sponsors:
University of Kiel
Conditions:
Hypercholesterolemia
Dyslipidemias
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol. The main...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age ≥ 18
- Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis
- LDL-C levels above risk-adapted target
- TG levels \< 400 mg/dL
- Stability of potential drug treatment during the last 4 weeks
- Stability of potential hormonal treatment during the last 6 months
- Patient was made aware of lifestyle measures by GP or specialist
- Consent to participation
- Sufficient knowledge of the German language
- Exclusion criteria
- Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes
- Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes
- Patients receiving plasmapheresis
- Lp(a) \> 50 mg/dL
- current pregnancy or planned pregnancy during the study period
- planned major operations
- liver dysfunction
- end-stage renal failure
- other systemic conditions that might interfere with successful study participation
- Plans to change drug (including hormonal) treatment in the upcoming 6 months
- Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past
Exclusion
Key Trial Info
Start Date :
February 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT05988866
Start Date
February 3 2025
End Date
January 1 2026
Last Update
August 22 2025
Active Locations (1)
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1
GAIA AG
Hamburg, Germany, 22085