NCT04066283

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4.7 years

First QC Date

June 17, 2019

Last Update Submit

September 13, 2024

Conditions

TransgenderGender IdentityVascular StiffnessVascular InflammationInsulin SensitivityBlood PressureLipid DisorderAppetitive Behavior

Outcome Measures

Primary Outcomes (1)

  • Evaluation of endothelial function (flow-mediated dilation (FMD)

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

    Baseline

Secondary Outcomes (25)

  • Evaluation of carotid artery compliance

    Baseline

  • Evaluation of carotid artery beta stiffness index

    Baseline

  • Carotid artery intimal-medial thickness

    Baseline

  • Evaluation of oxidant burden: oxidized LDL

    Baseline

  • Evaluation of oxidant burden: nitrotyrosine

    Baseline

  • +20 more secondary outcomes

Study Arms (2)

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

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

Interventions

No interventionOTHER

There was no intervention in this study

Older transgender womenYounger transgender women

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender women (people who were assigned male at birth but whose gender identity is female). They may or may not have legally changed their gender marker.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Endothelial cells

MeSH Terms

Conditions

Insulin ResistanceLipid Metabolism DisordersAppetitive Behavior

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior, AnimalBehavior

Study Officials

  • Sean Iwamoto, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

August 26, 2019

Study Start

April 17, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)