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

September 13, 2024 updated by: University of Colorado, Denver

Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age Group-Matched Cisgender Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Transgender women from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.

Description

Inclusion Criteria:

  • Aged 18-40 years old or 50-75 years old
  • Identify as a transgender woman
  • Have taken estradiol and spironolactone for at least one year
  • Currently taking oral or transdermal estradiol

Exclusion Criteria:

  • Don't identify as a transgender woman
  • Not currently taking estradiol or spironolactone
  • Have been on estradiol and spironolactone for less than one year
  • History of orchiectomy
  • Current tobacco smoker
  • Current illicit drug use
  • History of prior or active estrogen-dependent neoplasms
  • Acute liver or gallbladder disease
  • Venous thromboembolism
  • Hypertriglyceridemia >500 mg/dL
  • Fasted plasma glucose >7.0 mmol/L or previously treated diabetes
  • Resting blood pressure >140/90 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Older transgender women
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
There was no intervention in this study
Younger transgender women
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of endothelial function (flow-mediated dilation (FMD)
Time Frame: Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: Baseline
Baseline
Alcohol use
Time Frame: Baseline
Baseline
Blood pressure
Time Frame: Baseline
Baseline
Evaluation of carotid artery compliance
Time Frame: Baseline
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).
Baseline
Carotid artery intimal-medial thickness
Time Frame: Baseline
Baseline
Evaluation of oxidant burden: oxidized LDL
Time Frame: Baseline
Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.
Baseline
Evaluation of oxidant burden: nitrotyrosine
Time Frame: Baseline
Nitrotyrosine measured in the blood and endothelial cells.
Baseline
Evaluation of vascular endothelial cell inflammation: NFkB
Time Frame: Baseline
Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.
Baseline
Evaluation of vascular endothelial cell inflammation: MCP-1
Time Frame: Baseline
Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.
Baseline
Evaluation of vascular endothelial cell inflammation: IL-6
Time Frame: Baseline
Interleukin 6 (IL-6) measured in blood and endothelial cells.
Baseline
Evaluation of vascular endothelial cell inflammation: CRP
Time Frame: Baseline
C-reactive protein (CRP) measured in blood and endothelial cells.
Baseline
Plasma lipid concentrations: total cholesterol
Time Frame: Baseline
Total cholesterol will be determined at baseline.
Baseline
Plasma lipid concentrations: triglycerides
Time Frame: Baseline
Triglycerides will be determined at baseline.
Baseline
Whole body composition: Percent Lean Mass
Time Frame: Baseline
Percent lean mass will be determined using dual energy x-ray absorptiometry.
Baseline
Whole body composition: Percent Fat Mass
Time Frame: Baseline
Percent fat mass will be determined using dual energy x-ray absorptiometry.
Baseline
Regional body composition: Percent Lean Mass
Time Frame: Baseline
Regional percent lean mass will be determined using dual energy x-ray absorptiometry.
Baseline
Regional body composition: Percent Fat Mass
Time Frame: Baseline
Regional percent fat mass will be determined using dual energy x-ray absorptiometry.
Baseline
Appetite ratings
Time Frame: Baseline
Baseline
Appetite-related peptides
Time Frame: Baseline
Baseline
D-Dimer
Time Frame: Baseline
Baseline
Depression symptoms
Time Frame: Baseline
Baseline
Physical activity monitoring
Time Frame: 7 days
Physical activity will me monitored for 7 days with an ActivPALmonitor
7 days
Energy intake
Time Frame: 3 days
Energy intake will be estimated with a 3-day food diary
3 days
Evaluation of carotid artery beta stiffness index
Time Frame: Baseline
The carotid artery beta stiffness index indicates how stiff the artery is. Higher numbers are associated with worse outcomes (stiffer artery).
Baseline
Weight changes
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sean Iwamoto, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-2258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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