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.
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.
Study Type
OBSERVATIONAL
Enrollment
17
There was no intervention
University of Colorado
Aurora, Colorado, United States
Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: Baseline
Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: 1 month
Evaluation of endothelial function (flow-mediated dilation (FMD) at 6 Months
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: 6 month
Evaluation of endothelial function (flow-mediated dilation (FMD) at 12 Months
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Time frame: 12 month
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, 1 mo., 6 mo., 12 mo.
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, 1 mo., 6 mo., 12 mo.
Carotid artery intimal-medial thickness
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of oxidant burden: oxidized LDL
Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of oxidant burden: nitrotyrosine
Nitrotyrosine measured in the blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB)
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.
Evaluation of vascular endothelial cell inflammation: MCP-1
Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: IL-6
Interleukin 6 (IL-6) measured in blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: CRP
C-reactive protein (CRP) measured in blood and endothelial cells.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Blood pressure
Blood pressure will be measured at baseline, 1 mo., 6 mo. 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Plasma lipid concentrations: total cholesterol
Total cholesterol will be determined at baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Plasma lipid concentrations: triglycerides
Triglycerides will be determined at baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Insulin sensitivity
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Whole body composition: Percent Lean Mass
Percent lean mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 6 mo., 12 mo.
Whole body composition: Percent Fat Mass
Percent fat mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 6 mo., 12 mo.
Regional body composition: Percent Lean Mass
Regional percent lean mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 6 mo., 12 mo.
Regional body composition: Percent Fat Mass
Regional percent fat mass will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 6 mo., 12 mo.
Bone density
Bone density of femur and spine will be determined using dual energy x-ray absorptiometry.
Time frame: Baseline, 12 mo.
Weight changes
Body weight will be measured at baseline, 1 mo., 6 mo., 12 mo.
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Appetite ratings
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Appetite-related peptides
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
D-Dimer
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Alcohol use
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Depression symptoms
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Physical activity monitoring
Physical activity will me monitored for 7 days with an ActivPAL monitor
Time frame: 7 days at baseline, 1 mo., 6 mo., 12 mo.
Energy intake
Energy intake will be estimated with a 3-day food diary
Time frame: 3 days at baseline, 1 mo., 6 mo., 12 mo.
Sex hormone concentrations
Sex hormone concentrations of estradiol, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH) and sex hormone-binding globulin (SHBG) will be measured
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
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