Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls

Prospective Comparative Evaluation of the Biochemical and Clinical Effects of Different Dialysis Modalities on Cardiovascular Status and Bone Mineral Metabolism

This observational study will compare cardiovascular status, bone mineral metabolism, systemic inflammation, body composition, functional status, quality of life, pruritus, and pain among patients receiving different renal replacement therapy modalities and healthy controls.

Adult participants will be included in four groups: maintenance hemodialysis, continuous ambulatory peritoneal dialysis, automated peritoneal dialysis, and healthy controls. No new treatment, drug, dialysis modality, or experimental device will be assigned as part of the study. Participants will continue their routine clinical care.

Serum interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), fibroblast growth factor-23 (FGF-23), and sclerostin levels will be measured. Arterial stiffness will be assessed using pulse wave velocity (PWV), and body composition will be assessed using the Body Composition Monitor (BCM). Handgrip strength, quality of life, pruritus, and pain scores will also be evaluated.

The study will also explore correlations between biochemical biomarkers, arterial stiffness, body composition, and patient-reported outcomes. In the automated peritoneal dialysis group, objective treatment adherence will additionally be assessed using the Sharesource (Baxter/Vantive) cloud-based remote patient monitoring platform.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis; Peritoneal Dialysis (PD); End-Stage Kidney Disease (ESKD)

Detailed Description

Patients with end-stage kidney disease receiving renal replacement therapy have a high burden of cardiovascular disease, chronic inflammation, mineral and bone metabolism abnormalities, altered body composition, impaired quality of life, pruritus, and pain. Hemodialysis and peritoneal dialysis differ in clearance patterns, fluid management, and treatment delivery, which may influence biochemical, vascular, nutritional, and patient-reported outcomes.

This is a single-center observational clinical study including adult patients receiving routine renal replacement therapy and healthy controls. Participants will not be assigned to any intervention by the study protocol. Hemodialysis, continuous ambulatory peritoneal dialysis (CAPD), and automated peritoneal dialysis (APD) treatments will continue according to routine clinical practice and the decisions of the treating physicians.

The study will include 100 participants in four groups: 40 patients receiving maintenance hemodialysis, 20 patients receiving CAPD, 20 patients receiving APD, and 20 healthy controls. Dialysis patients will be evaluated at baseline, Month 3, Month 6, and Month 12. Healthy controls will be evaluated at baseline only.

The main objective is to compare patients receiving different dialysis modalities and healthy controls in terms of bone mineral metabolism, systemic inflammation, endothelial dysfunction, arterial stiffness, body composition, functional status, quality of life, pruritus, and pain. Serum sclerostin and fibroblast growth factor-23 (FGF-23) will be evaluated as bone mineral metabolism biomarkers. Serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) will be evaluated as inflammatory and endothelial dysfunction-related biomarkers. These biomarkers will be measured using enzyme-linked immunosorbent assay (ELISA).

For hemodialysis patients, blood samples will be obtained immediately before a mid-week dialysis session through the existing vascular access. For CAPD patients, APD patients, and healthy controls, fasting venous blood samples will be obtained in the morning. Serum samples will be processed and stored according to laboratory procedures until batch analysis.

Arterial stiffness will be assessed using pulse wave velocity (PWV). Body composition and fluid status will be assessed by bioimpedance analysis using the Fresenius Body Composition Monitor (BCM). Body composition parameters will include overhydration, extracellular water to total body water ratio, intracellular water, lean tissue index, body cell mass. Handgrip strength will be measured as a functional parameter.

Patient-reported outcomes will be assessed using the Kidney Disease Quality of Life-36 (KDQOL-36), the Uremic Pruritus in Dialysis Patients (UP-Dial) questionnaire, and the Short-Form McGill Pain Questionnaire (SF-MPQ), as applicable. In healthy controls, kidney disease-specific questionnaire components will not be applied; instead, the 12-Item Short Form Health Survey (SF-12) will be used to assess general health-related quality of life.

The study will also evaluate correlations between molecular biomarkers, instrumental measurements, and clinical scores. Specifically, the relationships between elevated biomarker levels, increased arterial stiffness, altered body composition, lower quality of life, pruritus, and pain burden will be explored.

As an additional objective, objective treatment adherence will be assessed in the APD group using data transferred from home cycler devices to the Sharesource (Baxter/Vantive) cloud-based remote patient monitoring platform. Adherence-related variables will include the percentage of completed sessions, lost dwell time, differences between prescribed and delivered ultrafiltration, and device bypass or manual intervention alarms. Full treatment adherence will be defined as completion of at least 90% of the prescribed dialysis session number and total prescribed dialysis duration.

No additional invasive procedure will be performed other than standard blood sampling for biomarker measurements. Pulse wave velocity and body composition measurements are non-invasive and will be performed using devices used in routine clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Veysel Baran Tomar, M.D.; Phone Number: +905334133253; Email: veyselbarantomar@gazi.edu.tr

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06500
      • Gazi University Faculty of Medicine, Department of Nephrology
      • Contact: Veysel Baran Tomar, M.D.; Phone Number: +905334133253; Email: veyselbarantomar@gazi.edu.tr
      • Contact: Omer Faruk Akcay, Associate Professor; Phone Number: +905546992867; Email: omerfarukakcay@gazi.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult participants will be recruited from the Gazi University Faculty of Medicine nephrology outpatient clinic and dialysis units. The study population will include four cohorts: patients receiving maintenance hemodialysis, patients receiving continuous ambulatory peritoneal dialysis, patients receiving automated peritoneal dialysis, and healthy controls without known kidney disease. Dialysis patients must have been receiving regular dialysis treatment for at least 6 months. Healthy controls will have no known kidney disease, systemic inflammatory disease, or active malignancy.

Description

Inclusion Criteria:

• Age 18 to 80 years.
• For dialysis cohorts: diagnosis of end-stage kidney disease and receiving maintenance hemodialysis or peritoneal dialysis.
• For dialysis cohorts: receiving regular hemodialysis, continuous ambulatory peritoneal dialysis, or automated peritoneal dialysis for at least 6 months.
• For healthy controls: no known kidney disease, with estimated glomerular filtration rate greater than 90 mL/min/1.73 m².
• For healthy controls: no known systemic inflammatory disease or active malignancy.
• Able to comply with planned study procedures, including pulse wave velocity measurement, Body Composition Monitor assessment, questionnaires, and biomarker measurements.
• Able and willing to provide written informed consent.

Exclusion Criteria:

• Inability to comply with study measurements or questionnaire assessments.
• Refusal or inability to provide written informed consent.
• Age younger than 18 years or older than 80 years.
• Acute infection.
• Recent major surgical intervention.
• Active malignancy.
• Terminal illness with limited life expectancy.
• Mental, cognitive, physical, or clinical condition preventing participation in study procedures.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Maintenance Hemodialysis; Adult patients with end-stage kidney disease who have been receiving maintenance hemodialysis for at least 6 months. Participants in this cohort will continue their routine hemodialysis treatment three times weekly according to standard clinical practice. No intervention will be assigned by the study protocol. Blood samples, pulse wave velocity, body composition measurements, handgrip strength, and patient-reported outcome assessments will be performed at baseline, Month 3, Month 6, and Month 12.
Continuous Ambulatory Peritoneal Dialysis; Adult patients with end-stage kidney disease who have been receiving continuous ambulatory peritoneal dialysis (CAPD) for at least 6 months. Participants in this cohort will continue their routine CAPD treatment according to standard clinical practice. No intervention will be assigned by the study protocol. Blood samples, pulse wave velocity, body composition measurements, handgrip strength, and patient-reported outcome assessments will be performed at baseline, Month 3, Month 6, and Month 12.
Automated Peritoneal Dialysis; Adult patients with end-stage kidney disease who have been receiving automated peritoneal dialysis (APD) for at least 6 months. Participants in this cohort will continue their routine APD treatment according to standard clinical practice. No intervention will be assigned by the study protocol. Blood samples, pulse wave velocity, body composition measurements, handgrip strength, and patient-reported outcome assessments will be performed at baseline, Month 3, Month 6, and Month 12. Objective treatment adherence will also be assessed using data transferred from home cycler devices to the Sharesource cloud-based remote patient monitoring platform.
Healthy Controls; Adult healthy controls without known kidney disease, systemic inflammatory disease, or active malignancy. Healthy controls will not receive any intervention assigned by the study protocol. Baseline blood samples, pulse wave velocity, body composition measurements, handgrip strength, pain assessment, and general health-related quality of life assessment using the 12-Item Short Form Health Survey (SF-12) will be performed. Healthy controls will be evaluated at baseline only and will not undergo longitudinal follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Interleukin-6 (IL-6) Concentration	Serum interleukin-6 (IL-6) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). Change in serum IL-6 concentration from baseline to Month 12 will be evaluated in dialysis cohorts, and baseline IL-6 concentrations will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) Concentration	Serum vascular cell adhesion molecule-1 (VCAM-1) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). Change in serum VCAM-1 concentration from baseline to Month 12 will be evaluated in dialysis cohorts, and baseline VCAM-1 concentrations will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Serum Sclerostin Concentration	Serum sclerostin concentration will be measured using enzyme-linked immunosorbent assay (ELISA). Change in serum sclerostin concentration from baseline to Month 12 will be evaluated in dialysis cohorts, and baseline sclerostin concentrations will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Serum Fibroblast Growth Factor-23 (FGF-23) Concentration	Serum fibroblast growth factor-23 (FGF-23) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). Change in serum FGF-23 concentration from baseline to Month 12 will be evaluated in dialysis cohorts, and baseline FGF-23 concentrations will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulse Wave Velocity (PWV) Measured in m/s	Pulse wave velocity (PWV) will be measured in meters per second (m/s) as a single parameter of arterial stiffness. Changes in PWV over time will be evaluated in dialysis cohorts, and baseline PWV values will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Handgrip Strength Measured by Hand Dynamometer	Handgrip strength will be measured in kilograms (kg) using a hand dynamometer as a functional parameter. Changes in handgrip strength over time will be evaluated in dialysis cohorts, and baseline handgrip strength values will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Kidney Disease Quality of Life-36 (KDQOL-36) Score	Health-related quality of life will be evaluated using the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire in dialysis cohorts. Changes in KDQOL-36 scores over time will be evaluated in hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis cohorts. Higher scores indicate better health-related quality of life and a better outcome.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Uraemic Pruritus in Dialysis Patients (UP-Dial) Score	Pruritus severity will be evaluated using the Uraemic Pruritus in Dialysis Patients (UP-Dial) scale in dialysis cohorts. The UP-Dial total score ranges from 0 to 56, with higher scores indicating more severe pruritus and a worse outcome.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) Total Pain Rating Index Score	Pain will be evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ) total Pain Rating Index score. The SF-MPQ total Pain Rating Index score is calculated from 15 pain descriptors, each scored from 0 to 3, resulting in a total score range of 0 to 45. Higher scores indicate greater pain severity and a worse outcome. Changes over time will be evaluated in dialysis cohorts, and baseline values will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Overhydration (OH) Measured by Body Composition Monitor	Overhydration (OH) will be measured in liters (L) using the Body Composition Monitor (BCM). Changes in OH over time will be evaluated in dialysis cohorts, and baseline OH values will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Extracellular Water to Total Body Water Ratio (ECW/TBW)	The extracellular water to total body water ratio (ECW/TBW) will be assessed using the Body Composition Monitor (BCM). Changes in ECW/TBW over time will be evaluated in dialysis cohorts, and baseline ECW/TBW values will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Intracellular Water (ICW) Measured by Body Composition Monitor	Intracellular water (ICW) will be measured in liters (L) using the Body Composition Monitor (BCM). Changes in ICW over time will be evaluated in dialysis cohorts, and baseline ICW values will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Lean Tissue Index (LTI) Measured by Body Composition Monitor	Lean tissue index (LTI) will be measured in kg/m² using the Body Composition Monitor (BCM). Changes in LTI over time will be evaluated in dialysis cohorts, and baseline LTI values will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.
Change in Body Cell Mass Measured by Body Composition Monitor	Body cell mass will be measured in kilograms (kg) using the Body Composition Monitor (BCM). Changes in body cell mass over time will be evaluated in dialysis cohorts, and baseline body cell mass values will be compared between dialysis modality groups and healthy controls.	Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General Publications

• Vo, H.H.T.; Nguyen, T.V.H.; Phan, M.P.T.; Vo, T. Serum Sclerostin Levels and Their Association with Mineral and Bone Disorders in Hemodialysis Versus Peritoneal Dialysis Patients: A Cross-Sectional Comparative Study in Vietnam. Kidney Dial. 2026, 6, 35. https://doi.org/10.3390/kidneydial6020035
• Lima F, Monier-Faugere MC, Mawad H, David V, Malluche HH. FGF-23 and sclerostin in serum and bone of CKD patients. Clin Nephrol. 2023 May;99(5):209-218. doi: 10.5414/CN111111.
• Yildirim M, Acikgoz SB, Genc AB, Yaylaci S, Dheir H, Sipahi SS. The levels of inflammatory biomarkers in hemodialysis and peritoneal dialysis patients. Rev Assoc Med Bras (1992). 2021 Jun;67(5):718-723. doi: 10.1590/1806-9282.20210056.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pulse Wave Velocity; Hemodialysis; Sclerostin; Interleukin-6; Continuous Ambulatory Peritoneal Dialysis; Fibroblast Growth Factor-23; Body Composition Monitor; Automated Peritoneal Dialysis; Sharesource; Vascular Cell Adhesion Molecule-1; Kidney Disease Quality of Life-36; Uremic Pruritus in Dialysis Patients; Short-Form McGill Pain Questionnaire
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Sclerosteosis
• Other Study ID Numbers: GAZI-HD-PD-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) are not planned to be shared publicly. The study is a single-center observational study with a limited number of participants, and the dataset may include sensitive clinical, laboratory, questionnaire, and treatment adherence data. All data will be stored in coded form and managed in accordance with institutional policies, ethical requirements, and applicable data protection regulations. De-identified aggregate results may be reported in scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No