Cholesterol Metabolism in Plasma and Interstitial Fluid Among Subjects Undergoing Hemodialysis.

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03921216

Enrollment

Registered

2019-04-19

Start date

2019-04-17

Completion date

2027-12-31

Last updated

2025-03-19

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

Conditions

Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Diabetic Nephropathies

Brief summary

Because the atherosclerosis process partly occur in the intercellular space of the vessel wall, the determination of the constitution of lipoproteins in the interstitial fluid may expand the knowledge about the atherosclerosis process and lead to a better understanding of what constitutes the increased risk of developing cardiovascular disease in patients with chronic diseases. The investigators hypothesize that the apoB-containing particles in T2D patients are more susceptible to be retained or consumed in the intercellular compartment, which in turn could be one explanation for the elevated risk of atherosclerosis. The investigators hypothesise that with the progression of chronic kidney disease this process is further increased. Patients undergoing dialysis are known to have a very high risk of cardiovascular disease. The investigators now want to study the cholesterol metabolism in interstitial fluid in subjects undergoing hemodialysis because of diabetic nephropathy and in subjects undergoing hemodialysis because of chronic kidney disease of other causes.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis.

Exclusion criteria

* Active infection that increases the risk of secondary infection in the skin where the vesicles containing interstitial fluid have been emptied of interstitial fluid with a fine needle and the bladder roof is intact. * Treatment with Warfarin due to increased risk of Calciphylaxis (calcific uremic arteriolopathy, CUA)

Design outcomes

Primary

Measure	Time frame
Interstitial fluid-to-serum ratio for LDL cholesterol	2 hours

Countries

Sweden

Outcome results