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SuspendedNCT03921216Updated Mar 19, 2025

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

An observational study in Diabetes Mellitus, Type 2, Diabetic Nephropathies and Chronic Kidney Diseases, sponsored by Karolinska University Hospital. Suspended at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Karolinska University Hospital · Observational

Why this study was suspended
Covid19
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Diabetes Mellitus, Type 2
  • Diabetic Nephropathies
  • Chronic Kidney Diseases
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 20 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Diabetic nephropathy, on hemodialysis
  • Chronic kidney disease, on hemodialysis

    Chronic kidney disease of other causes than Diabetes.

  • Chronic kidney disease, predialysis

    Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge

  • Diabetic nephropathy, predialysis

    Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge

06

What researchers measure

Primary outcomes

  1. Interstitial fluid-to-serum ratio for LDL cholesterol

    Time frame: 2 hours

07

Study locations

1 site
  • Dialysis Unit, M87-89, Karolinska University Hospital, Huddinge
    Stockholm, 14186, Sweden
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03921216
Lead sponsor
Karolinska University Hospital
Responsible party
Mats Rudling (Professor, Karolinska University Hospital) — Principal investigator
First posted
Apr 19, 2019
Start date
Apr 17, 2019
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 19, 2025

Study contacts

Mats Rudling
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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