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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;
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STUDY GROUP | Other | THE ONLY GROUP IN THE STUDY.MEASUREMENT OF CIMT,FMD,NC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonographic and Capillary Measurements | Diagnostic Test | All measurements will be applied to the entire patient group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of serum sVE cadherin level and other measurements | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alper Alp, Assoc Prof,MD | Muğla Sıtkı Koçman University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mugla Sitki Kocman University | Muğla | Muğla | 48000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35806017 | Background | Harki O, Bouyon S, Salle M, Arco-Hierves A, Lemarie E, Demory A, Chirica C, Vilgrain I, Pepin JL, Faury G, Briancon-Marjollet A. Inhibition of Vascular Endothelial Cadherin Cleavage Prevents Elastic Fiber Alterations and Atherosclerosis Induced by Intermittent Hypoxia in the Mouse Aorta. Int J Mol Sci. 2022 Jun 24;23(13):7012. doi: 10.3390/ijms23137012. | |
| 14695457 |
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There is no plan to share individual data from this study.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Soeki T, Tamura Y, Shinohara H, Sakabe K, Onose Y, Fukuda N. Elevated concentration of soluble vascular endothelial cadherin is associated with coronary atherosclerosis. Circ J. 2004 Jan;68(1):1-5. doi: 10.1253/circj.68.1. |
| 28561330 | Background | Chang F, Flavahan S, Flavahan NA. Impaired activity of adherens junctions contributes to endothelial dilator dysfunction in ageing rat arteries. J Physiol. 2017 Aug 1;595(15):5143-5158. doi: 10.1113/JP274189. Epub 2017 Jun 30. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |