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

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ClinicalTrials.gov Identifier: NCT04066283
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
Transgenderism Gender Identity Vascular Stiffness Vascular Inflammation Insulin Sensitivity Blood Pressure Lipid Disorder Appetitive Behavior

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.
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.



Primary Outcome Measures :
  1. Evaluation of endothelial function (flow-mediated dilation (FMD) [ Time Frame: Baseline ]
    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Carotid artery intimal-medial thickness [ Time Frame: Baseline ]
  4. Evaluation of oxidant burden: oxidized LDL [ Time Frame: Baseline ]
    Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.

  5. Evaluation of oxidant burden: nitrotyrosine [ Time Frame: Baseline ]
    Nitrotyrosine measured in the blood and endothelial cells.

  6. 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.

  7. Evaluation of vascular endothelial cell inflammation: MCP-1 [ Time Frame: Baseline ]
    Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.

  8. Evaluation of vascular endothelial cell inflammation: IL-6 [ Time Frame: Baseline ]
    Interleukin 6 (IL-6) measured in blood and endothelial cells.

  9. Evaluation of vascular endothelial cell inflammation: CRP [ Time Frame: Baseline ]
    C-reactive protein (CRP) measured in blood and endothelial cells.

  10. Blood pressure [ Time Frame: Baseline ]
  11. Plasma lipid concentrations: total cholesterol [ Time Frame: Baseline ]
    Total cholesterol will be determined at baseline.

  12. Plasma lipid concentrations: triglycerides [ Time Frame: Baseline ]
    Triglycerides will be determined at baseline.

  13. Insulin sensitivity [ Time Frame: Baseline ]
  14. Whole body composition: Percent Lean Mass [ Time Frame: Baseline ]
    Percent lean mass will be determined using dual energy x-ray absorptiometry.

  15. Whole body composition: Percent Fat Mass [ Time Frame: Baseline ]
    Percent fat mass will be determined using dual energy x-ray absorptiometry.

  16. Regional body composition: Percent Lean Mass [ Time Frame: Baseline ]
    Regional percent lean mass will be determined using dual energy x-ray absorptiometry.

  17. Regional body composition: Percent Fat Mass [ Time Frame: Baseline ]
    Regional percent fat mass will be determined using dual energy x-ray absorptiometry.

  18. Weight changes [ Time Frame: Baseline ]
  19. Appetite ratings [ Time Frame: Baseline ]
  20. Appetite-related peptides [ Time Frame: Baseline ]
  21. D-Dimer [ Time Frame: Baseline ]
  22. Alcohol use [ Time Frame: Baseline ]
  23. Depression symptoms [ Time Frame: Baseline ]
  24. Physical activity monitoring [ Time Frame: 7 days ]
    Physical activity will me monitored for 7 days with an ActivPALmonitor

  25. Energy intake [ Time Frame: 3 days ]
    Energy intake will be estimated with a 3-day food diary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Transgender 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.
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.
Criteria

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 thromobembolism
  • Hypertriglyceridemia >500 mg/dL
  • Fasted plasma glucose >7.0 mmol/L or previously treated diabetes
  • Resting blood pressure >140/90 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066283


Contacts
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Contact: Sean Iwamoto, MD 303-724-3662 sean.iwamoto@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Sean Iwamoto, MD    303-724-3662    sean.iwamoto@cuanschutz.edu   
Principal Investigator: Sean Iwamoto, MD         
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Sean Iwamoto, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04066283    
Other Study ID Numbers: 18-2258
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Lipid Metabolism Disorders
Inflammation
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases