University of Colorado
Aurora, Colorado, 80045, United States
NCT Number: NCT05195164
This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.
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Notify Me18 year–99 year
All sexes
Observational
Aurora, Colorado, 80045, United States
The global aim of this study is to characterize cardiometabolic risk (measured by vascular, metabolic and biochemical factors-which have not been extensively studied prospectively) in trans women before and after orchiectomy. Trans women appear to be at greater risk for cardiovascular disease (CVD) and blood clots compared to non-trans adults. The effect of orchiectomy on CVD risk among trans women is unknown, but orchiectomy may change blood vessel function and metabolic health. The investigators will examine blood vessel function and metabolic profiles of trans women before and at several timepoints after orchiectomy to identify age-related differences in CVD risk factors. This knowledge may lead to new approaches to prevent CVD in trans women as well as all people regardless of gender identity.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There was no intervention
Time frame: Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: 1 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: 6 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: 12 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
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, 1 mo., 6 mo., 12 mo.
The carotid artery beta stiffness index indicates how stiff the artery is. Higher numbers are associated with worse outcomes (stiffer artery).
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Nitrotyrosine measured in the blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Interleukin 6 (IL-6) measured in blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
C-reactive protein (CRP) measured in blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Blood pressure will be measured at baseline, 1 mo., 6 mo. 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Total cholesterol will be determined at baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Triglycerides will be determined at baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 6 mo., 12 mo.
Percent lean mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 6 mo., 12 mo.
Percent fat mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 6 mo., 12 mo.
Regional percent lean mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 6 mo., 12 mo.
Regional percent fat mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 12 mo.
Bone density of femur and spine will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Body weight will be measured at baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Time frame: 7 days at baseline, 1 mo., 6 mo., 12 mo.
Physical activity will me monitored for 7 days with an ActivPAL monitor
Time frame: 3 days at baseline, 1 mo., 6 mo., 12 mo.
Energy intake will be estimated with a 3-day food diary
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Sex hormone concentrations of estradiol, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH) and sex hormone-binding globulin (SHBG) will be measured
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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