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

NCT03921216 | Suspended

• 1 other identifier: CKDIC2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Interstitial fluid-to-serum ratio for LDL cholesterol

  2 hours

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

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

Stockholm, 14186, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, interstitial fluid

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mats Rudling

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: April 17, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)