An observational study in Transgender, Gender Identity and Vascular Stiffness, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Colorado, Denver · Observational
This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in younger versus older transgender women (people who were assigned male at birth but whose gender identity is female). Data will also be compared to those from cisgender women and men.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 29 is below the median of 80 across 339 observational studies indexed under Insulin Resistance.
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Transgender women from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.
Exclusion Criteria:
This cohort will consist of transgender women aged 50-75 years old who have taken estradiol and spironolactone for at least one year.
Other: No intervention
This cohort will consist of transgender women aged 18-40 years old who have taken estradiol and spironolactone for at least one year.
Other: No intervention
There was no intervention in this study
Evaluation of endothelial function (flow-mediated dilation (FMD)
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: Baseline
Evaluation of carotid artery compliance
The carotid artery compliance index indicates how elastic the artery is. The index describes the change in arterial blood volume in response to a change in arterial blood pressure. Lower numbers are associated with worse outcomes (less elastic arteries).
Time frame: Baseline
Evaluation of carotid artery beta stiffness index
The carotid artery beta stiffness index indicates how stiff the artery is. Higher numbers are associated with worse outcomes (stiffer artery).
Time frame: Baseline
Carotid artery intimal-medial thickness
Time frame: Baseline
Evaluation of oxidant burden: oxidized LDL
Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.
Time frame: Baseline
Evaluation of oxidant burden: nitrotyrosine
Nitrotyrosine measured in the blood and endothelial cells.
Time frame: Baseline
Evaluation of vascular endothelial cell inflammation: NFkB
Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.
Time frame: Baseline
Evaluation of vascular endothelial cell inflammation: MCP-1
Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.
Time frame: Baseline
Evaluation of vascular endothelial cell inflammation: IL-6
Interleukin 6 (IL-6) measured in blood and endothelial cells.
Time frame: Baseline
Evaluation of vascular endothelial cell inflammation: CRP
C-reactive protein (CRP) measured in blood and endothelial cells.
Time frame: Baseline
Blood pressure
Time frame: Baseline
Plasma lipid concentrations: total cholesterol
Total cholesterol will be determined at baseline.
Time frame: Baseline
Plasma lipid concentrations: triglycerides
Triglycerides will be determined at baseline.
Time frame: Baseline
Insulin sensitivity
Time frame: Baseline
Whole body composition: Percent Lean Mass
Percent lean mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline
Whole body composition: Percent Fat Mass
Percent fat mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline
Regional body composition: Percent Lean Mass
Regional percent lean mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline
Regional body composition: Percent Fat Mass
Regional percent fat mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline
Weight changes
Time frame: Baseline
Appetite ratings
Time frame: Baseline
Appetite-related peptides
Time frame: Baseline
D-Dimer
Time frame: Baseline
Alcohol use
Time frame: Baseline
Depression symptoms
Time frame: Baseline
Physical activity monitoring
Physical activity will me monitored for 7 days with an ActivPALmonitor
Time frame: 7 days
Energy intake
Energy intake will be estimated with a 3-day food diary
Time frame: 3 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver