An observational study in Chronic Kidney Diseases, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by University of Colorado, Denver · Observational
The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in the field of nephrology focuses on male patients, and studies on women's vascular health are limited. Moreover, endogenous sex hormones, particularly estradiol, are well-documented to be cardioprotective in women without CKD; however, the role of sex hormones on vascular function in women with CKD remains unclear. The goals of the proposed project are: 1) to evaluate vasuclar function in pre- and post-menopausal women with CKD vs. age-matched healthy women; 2) to evaluate sex hormone concentrations and determine whether they associate with vascular function in the proposed cohort; and 3) to gain mechanistic insight on the association between sex hormones and vascular dysfunction in the proposed cohort.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's enrollment of 51 is below the median of 200 across 867 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pre- and post-menopausal women with CKD vs. age-matched healthy women
Exclusion Criteria:
Age 18-44 years CKD stage 3-4 (eGFR 15-59 ml/min/1.73m2)
Other: No intervention
Age 55-75 years CKD stage 3-4 (eGFR 15-59 ml/min/1.73m2)
Other: No intervention
Age 18-44 years Regular menstrual cycle (25-35 d)
Other: No intervention
Age 55-75 years
Other: No intervention
No intervention
Brachial Artery Flow-Mediated Dilation
Flow-mediated dilation of the brachial artery will be performed using ultrasonography and analyzed with a commercially available software package as percent change in diameter from baseline following reactive hyperemia.
Time frame: Baseline
Carotid Femoral Pulse Wave Velocity
A transcutaneous custom tonometer \[Noninvasive Hemodynamics Workstation (NIHem), Cardiovascular Engineering Inc.\] will be used to non-invasively assess carotid femoral pulse wave velocity.
Time frame: Baseline
Serum Sex Hormones
Serum sex hormones \[follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, prolactin, sex hormone binding globulin (SHBG), and anti-mullerian hormone (AMH)\] will be measured using chemiluminescent assays.
Time frame: Baseline
Urinary Sex Hormones
Urinary sex hormones \[follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrone-3-glucuronide (E1c), and pregnanediol-3-glucuronide (Pdg)\] will be measured by by chemiluminescent assays using ACS-180 Autoanalyzer.
Time frame: Baseline
Circulating/Urinary Markers of Antioxidant Status/Oxidative stress
Serum TAS, plasma/urinary 8-isoprostane, 8-OHdG will be measured using ELISA.
Time frame: Baseline
Circulating Markers of Inflammation
Plasma CRP, IL-1β, IL-6, and TNF-α will be measured using ELISA
Time frame: Baseline
Cytokine secretion from lipopolysaccharide(LPS)-stimulated peripheral blood mononuclear cells (PBMCs)
PBMCs will be isolated from heparinized whole blood using Cell Preparation Tube, PBMCs will be cultured with LPS, and supernatants will be harvested after 4-hour stimulation at 37°C. IL-1β, IL-6, and TNF-α in the supernatants will be measured using ELISA.
Time frame: Baseline
Distribution of Monocyte Subsets
PBMCs will be stained with fluorescence-labeled antibodies for monocyte (CD14 and CD16) and analyzed using an LSR II flow cytometer.
Time frame: Baseline
Ex Vivo Nitric Oxide Production from Human Umbilical Vein Endothelial Cells (HUVECs)
HUVECs will be incubated with basal media supplemented with 10% human serum collected from participants and stained with the fluorescent probe DAF-FM diacetate to detect nitric oxide production production in response to acetylcholine.
Time frame: Baseline
Ex Vivo Reactive Oxygen Species Production from Human Umbilical Vein Endothelial Cells (HUVECs)
HUVECs will be incubated with basal media supplemented with 10% human serum collected from participants and stained with the fluorescent probe DAF-FM diacetate to detect reactive oxygen species production in response to acetylcholine.
Time frame: Baseline
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in CKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver