Transgenderism Clinical Trial
Official title:
Defining the Cardiometabolic Profile of Transgender Boys and Men on Testosterone Therapy
Verified date | May 2023 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Transgender individuals are those with a gender identity opposite the sex they were assigned at birth. Approximately 1% of the population is transgender, equating to ~60,000 transgender Wisconsinites. A transgender boy or man is someone with a 46,XX karyotype and typical female genitalia but a male gender identity and desire for more male-typical gender expression. Gender-affirming testosterone (hormonal) treatment (GAHT) is the cornerstone of masculinizing therapy for transgender men and boys, resulting in estrogen (E2) suppression and circulating testosterone (T) levels equivalent to cisgender males. Historically, GAHT was initiated after an E2-driven puberty, but the last decade has seen an explosion of referrals for GAHT in transboys, many of whom are exposed to only low E2 levels before puberty is halted with blocker therapy. Knowledge of risks incurred by GAHT rely on low-quality studies, precluding conclusive assessment of GAHT's long-term impact on cardiometabolic outcomes. Data on transboys receiving GAHT before completion of E2-driven puberty are sparser and no studies have addressed mechanisms by which GAHT may affect vascular physiology. The investigators aim to determine the cardiometabolic impact of GAHT in transboys/men and to determine if any differences identified are mechanistically dependent on the timing of GAHT relative to puberty.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 1, 2026 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 30 Years |
Eligibility | Inclusion Criteria: - INCLUSION CRITERIA FOR TRANSGENDER BOYS AND TRANSGENDER MEN 1. Sex assigned female at birth and a male gender identity (i.e., transgender male) 2. Aged 12-30 years 3. Have a care provider in the Children's Wisconsin Gender Health Clinic or Froedtert Hospital Inclusion Clinic who has determined the individual meets clinical criteria to start testosterone therapy and plans to initiate this therapy 4. Naïve to testosterone or other masculinizing medical therapy 5. Cisgender girls/women and transgender boys/men of child-bearing potential (defined as having achieved menarche (first menses), excluding those who have had a hysterectomy or are on GnRH agonist therapy (puberty blockers)) must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit 6. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is < 18 years of age INCLUSION CRITERIA FOR CISGENDER INDIVIDUALS 1. Gender identity concordant with sex assigned at birth (i.e., cisgender) 2. Aged 12-30 years 3. Not related to a transgender participant enrolled in the study 4. Naïve to any sex hormone or pubertal blocker therapy or, specific to cisgender girls/women only, must be = 1 year from use of oral contraceptive or other contraceptive technique (intrauterine device, medroxyprogesterone injections) 5. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is < 18 years of age INCLUSION CRITERIA FOR OPTIONAL NITROGLYCERIN ENDOTHELIUM-INDEPENDENT VASCULAR FUNCTION STUDY 1. Aged = 18 years 2. No history of migraine headaches 3. Systolic blood pressure = 110 mm Hg 4. No prior past adverse reaction to nitroglycerin 5. Has not used a PDE5 inhibitor (i.e., sildenafil, tadalafil, vardenafil) in the past 7 days Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | Advancing a Healthier Wisconsin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by brachial artery ultrasound flow-mediated dilation | Investigators will examine the effects of gender-affirming testosterone therapy on in vivo endothelial function by brachial artery ultrasound flow-mediated dilation across study visits. | 1 year from baseline study visit | |
Primary | Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by by blood pressure. | Investigators will examine the effects of gender-affirming testosterone therapy on in vivo endothelial function by blood pressure. | 1 year from baseline study visit | |
Primary | Change in vascular endothelial function after one year of gender-affirming testosterone therapy as measured by circulating markers of endothelial activation as measured by plasma analysis | Investigators will examine the effects of gender-affirming testosterone therapy on in vivo endothelial function by circulating markers of endothelial activation as measured by plasma analysis. | 1 year from baseline study visit | |
Secondary | Change in body composition after one year of gender-affirming testosterone therapy as measured by BMI | Investigators will examine the effect of gender-affirming testosterone therapy on body composition as quantified by body mass index (BMI). | 1 year from baseline study visit | |
Secondary | Change in body composition after one year of gender-affirming testosterone therapy as measured by DXA scans. | Investigators will examine the effect of gender-affirming testosterone therapy on body composition as quantified by total body dual-energy X-ray absorptiometry (DXA) scan which provides information about the amount and distribution of fat and muscle in the body. | 1 year from baseline study visit | |
Secondary | Change in body composition after one year of gender-affirming testosterone therapy as measured by the ratio of waist-to-hip circumference. | Investigators will examine the effect of gender-affirming testosterone therapy on body composition as quantified by the ratio of waist-to-hip circumference which provides information about the amount and distribution of fat and muscle in the body. | 1 year from baseline study visit | |
Secondary | Change in lipid profile after one year of gender-affirming testosterone therapy | Investigators will measure the effect of gender-affirming testosterone therapy on the various components of a fasting lipid profile (triglyceride level, HDL, LDL, and total cholesterol). | 1 year from baseline study visit | |
Secondary | Change in systemic inflammation after one year of gender-affirming testosterone therapy | Investigators will examine the effect of gender-affirming testosterone therapy on circulating levels of inflammatory cytokines as measured by plasma analysis. | 1 year from baseline study visit | |
Secondary | Change in glucose metabolism after one year of gender-affirming testosterone therapy as measured by fasting insulin level in the blood. | Investigators will examine the effect of gender-affirming testosterone therapy on fasting insulin. | 1 year from baseline study visit | |
Secondary | Change in glucose metabolism after one year of gender-affirming testosterone therapy as measured by fasting blood glucose level. | Investigators will examine the effect of gender-affirming testosterone therapy on fasting glucose. | 1 year from baseline study visit | |
Secondary | Change in glucose metabolism after one year of gender-affirming testosterone therapy as measured by HbA1c | Investigators will examine the effect of gender-affirming testosterone therapy on HbA1c levels. | 1 year from baseline study visit |
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