Evaluation of Endothelial Dysfunction in Geriatric Non-dialysis Chronic Kidney Disease Patients (EDGeriatrCKD)

February 20, 2026 updated by: Alper Alp, Muğla Sıtkı Koçman University

Brief summary template

The goal of this clinical trial is to assess endothelial dysfunction in geriatric non-dialysis CKD patients. The main questions it aims to answer are:

• In geriatric non-dialysis CKD patients, the study aimed to demonstrate the relationship between soluble vascular endothelial cadherin and fibroblast growth factor-23 levels, which are indicators of endothelial dysfunction-and therefore a possible cardiovascular risk factor-using measurement methods such as ultrasonographic carotid intima-media thickness, flow-mediated dilation, and nailfold capillaroscopy.

Participants will have measurement of;

  • ultrasonographic carotid intima-media thickness,
  • flow-mediated dilation,
  • nailfold capillaroscopy
  • venous blood sampling
  • Visit the clinic once,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this single-center study, we aimed to evaluate endothelial dysfunction, the leading cause of mortality in geriatric CKD patients. We kept patient exclusion criteria strict and considered it more rational to conduct this study in a patient group requiring proactive intervention by excluding patients with 'known' cardiovascular disease. For this purpose, we used some non-invasive parameters known in the literature (ultrasonographic measurement of carotid intima-media thickness, nailfold capillaroscopy, flow-mediated dilation). We also planned to measure serum sVE Cadherin levels, which have not been clearly evaluated in geriatric CKD patients before, as well as serum FGF23 levels. We also planned to evaluate the relationship and correlation of these different parameters with other standard biochemical and anthropometric measurements. Patient recruitment for the study took place between May 12, 2023, and September 11, 2023. We followed up for mortality for approximately 2.3 years.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Muğla
      • Muğla, Muğla, Turkey (Türkiye), 48000
        • Mugla Sitki Kocman University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with CKD who are not receiving RRT and those aged 65 and over

Exclusion Criteria:

  • Patients under 65 years of age
  • history of coronary artery disease
  • history of peripheral artery disease
  • atrial fibrillation
  • heart failure
  • active immunosuppressive use
  • active infection
  • history of active malignancy
  • history of cerebrovascular event (ischemic/hemorrhagic)
  • Raynaud's phenomenon
  • renal transplant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: STUDY GROUP
THE ONLY GROUP IN THE STUDY.MEASUREMENT OF CIMT,FMD,NC.
Diagnostic test: Ultrasonographic and Capillary Measurements
All measurements will be applied to the entire patient group.
Other Names:
  • measurement of flow-mediated dilation
  • measurement of nailfold capillaroscopy
  • measurement of ultrasonographic carotid intima-media thickness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of serum sVE cadherin level and other measurements
Time Frame: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
To investigate the relationship between sVE cadherin levels and ultrasonographic carotid intima-media thickness (CIMT), flow-mediated dilation(FMD), nailfold capillaroscopy(NC) test results measured in patients.
Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
Distribution of sVE cadherin levels in the patient group
Time Frame: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
sVE cadherin levels
Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
Evaluation of those who died and those who survived after approximately over 2 years.
After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: Alper Alp, Assoc Prof,MD, Muğla Sıtkı Kocman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Actual)

September 11, 2023

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/159/02/3/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual data from this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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