Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

1. to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
2. to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Hormone Therapy on Renal Function

NCT04482920

Transgenderism Kidney Diseases Kidney Injury

COMPLETED

Impact of Estradiol Addback

NCT01862835

Normal Healthy Volunteers

COMPLETED PHASE1

Pubertal Blockade and Hormone Therapy in Transgender Youth

NCT03557268

Gender Identity Gender Dysphoria Gender Identity Disorder in Adolescence and Adulthood

COMPLETED

Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men

NCT04237467

Transgender Gender Identity Vascular Stiffness +4 more

COMPLETED

Pubertal Induction in Individuals With Hypogonadism

NCT02871986

Primary Amenorrhoea Hypothalamic Amenorrhoea Hypogonadotrophic Hypogonadism +3 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants are screened for eligibility.

Study involves a 4.5 hour morning in the lab:

1. Participants come fasting
2. IV infusion and blood draws
3. Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hormone Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cisgender and transgender women

Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.

Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.

Captopril Tablets

Intervention Type DRUG

Captorpril challenge to each participant

Iohexol

Intervention Type DRUG

Iohexol infusion to evaluate measured GFR

Cisgender and transgender men

Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.

Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.

Captopril Tablets

Intervention Type DRUG

Captorpril challenge to each participant

Iohexol

Intervention Type DRUG

Iohexol infusion to evaluate measured GFR

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Captopril Tablets

Captorpril challenge to each participant

Intervention Type DRUG

Iohexol

Iohexol infusion to evaluate measured GFR

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Capoten Omnipaque

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 to 90 years
* Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)

Exclusion Criteria

* Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
* Cerebrovascular disease (transient ischemic attacks or stroke)
* History of hypertension (BP\>140/90 or use of antihypertensive medications)
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
* Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose \>7mmol/L)
* Current smoker
* Previous history of preeclampsia
* Anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes