The modification of cardiometabolic and pro-atherogenic parameters through weight-reducing interventions and their influence on endothelial foam cell formation, vascular calcification potential, and cardiomyocyte function as a model of the controlled normalization of the metabolic state.

The modification of cardiometabolic and pro-atherogenic parameters through weight-reducing interventions and their influence on endothelial foam cell formation, vascular calcification potential, and cardiomyocyte function as a model of the controlled normalization of the metabolic state. - OBELISK: Obesity, Endothelial Lipid function, Inflammation and Systemic Cardiovascular risk

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039287

Enrollment

300

Registered

2026-02-09

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E66.0

Interventions

Group 1: Arm 1: BMI =40 kg/m² and bariatric procedure independent of the study in accordance with the German S3 guideline Surgery of Obesity and Metabolic Diseases. Group 2: Arm 2: BMI =35 and <40 kg/

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Arm 1: BMI = 40 kg/m² undergoing bariatric surgery according to S3 guidelines. Arm 2: BMI = 35 and < 40 kg/m² treated with GLP-1 receptor agonists. Arm 3: BMI = 35 kg/m² receiving conservative multimodal therapy

Exclusion criteria

Exclusion criteria: Patients under 18 years of age, coronary artery disease, active or previous malignancy, manifest diabetes mellitus, end-stage renal insufficiency (GFR < 15 mL/min), rheumatologic diseases, known psoriasis, and pregnancy

Design outcomes

Primary

Measure	Time frame
Primary endpoints: Change in HDL function Change in the in-vitro initiation of atherosclerotic plaque formation via foam cell formation Determination of in-vitro vascular calcification potential Change in cardiomyocyte and endothelial cell function Change in vascular and circulatory function (arterial function analysis, endothelial function, blood pressure, heart rate variability, diastolic function) Follow-up: -up visits are conducted at 3 months (T1), 6 months (T2), and 12 months (T3) as routine, study-independent controls at the obesity centers. During these visits, routine blood sampling is performed, from which an additional 30 mL of serum and a urine sample are obtained for study purposes; standardized questionnaires are also administered. After 12 months, a repeated comprehensive non-invasive cardiovascular assessment is carried out. A final telephone interview takes place at 60 months. Methodological assessment of primary endpoints Primary endpoints are assessed using a translational approach combining in-vitro models, biochemical analyses, non-invasive cardiovascular functional measurements, and validated questionnaires: - HDL function: Quantification of oxidized HDL - Atherogenesis / foam cell formation: Evaluation of transendothelial migration of human monocytes and their differentiation into foam cells in a HUVEC-based in-vitro atherogenesis model - Vascular calcification potential: Analysis of osteogenic differentiation of vascular smooth muscle cells isolated from arterial tissue obtained during bariatric surgery - Cardiomyocyte and endothelial cell function: Incubation of isolated human cells with patient serum followed by functional characterization using video microscopy, impedance measurements, and proteomic analyses - Vascular and circulatory function: Non-invasive measurements including flow-mediated dilation (FMD), pulse wave velocity, central aortic pressure, retinal vessel analysis, ambulatory blood pressure monitoring, long-term ECG, t	—

Measure

Time frame

Primary endpoints: Change in HDL function Change in the in-vitro initiation of atherosclerotic plaque formation via foam cell formation Determination of in-vitro vascular calcification potential Change in cardiomyocyte and endothelial cell function Change in vascular and circulatory function (arterial function analysis, endothelial function, blood pressure, heart rate variability, diastolic function) Follow-up: -up visits are conducted at 3 months (T1), 6 months (T2), and 12 months (T3) as routine, study-independent controls at the obesity centers. During these visits, routine blood sampling is performed, from which an additional 30 mL of serum and a urine sample are obtained for study purposes; standardized questionnaires are also administered. After 12 months, a repeated comprehensive non-invasive cardiovascular assessment is carried out. A final telephone interview takes place at 60 months. Methodological assessment of primary endpoints Primary endpoints are assessed using a translational approach combining in-vitro models, biochemical analyses, non-invasive cardiovascular functional measurements, and validated questionnaires: - HDL function: Quantification of oxidized HDL - Atherogenesis / foam cell formation: Evaluation of transendothelial migration of human monocytes and their differentiation into foam cells in a HUVEC-based in-vitro atherogenesis model - Vascular calcification potential: Analysis of osteogenic differentiation of vascular smooth muscle cells isolated from arterial tissue obtained during bariatric surgery - Cardiomyocyte and endothelial cell function: Incubation of isolated human cells with patient serum followed by functional characterization using video microscopy, impedance measurements, and proteomic analyses - Vascular and circulatory function: Non-invasive measurements including flow-mediated dilation (FMD), pulse wave velocity, central aortic pressure, retinal vessel analysis, ambulatory blood pressure monitoring, long-term ECG, t

—

Secondary

Measure	Time frame
Percentage weight loss after 12 months and its correlation with inflammatory parameters Markers of chronic inflammation (hs-CRP, cytokines) Metabolic parameters (glucose metabolism, lipid metabolism and lipid function) Change in hormonal status Quality of life	—

Countries

Germany

Contacts

Public ContactBenjamin Sasko

Universitätsklinikum Marien Hospital Herne, Ruhr-Universität Bochum

benjamin.sasko@rub.de+49 2323 499 5600

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026