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

NCT ID: NCT03921216

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-17

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Diabetic Nephropathies Chronic Kidney Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetic nephropathy, on hemodialysis

No interventions assigned to this group

Chronic kidney disease, on hemodialysis

Chronic kidney disease of other causes than Diabetes.

No interventions assigned to this group

Chronic kidney disease, predialysis

Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge

No interventions assigned to this group

Diabetic nephropathy, predialysis

Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mats Rudling

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mats Rudling

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Dialysis Unit, M87-89, Karolinska University Hospital, Huddinge

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CKDIC2

Identifier Type: -

Identifier Source: org_study_id

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