TERMINATED

Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will test: 1. whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function 2. whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function 3. whether estrogen therapy leads to enhanced immune response in older transwormen

Official Title

Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

Quick Facts

Study Start:2020-06-17
Study Completion:2025-03-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04515472

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy volunteers: healthy male or female
  2. * MTF transgender
  3. * FTM transgender
  4. * Non-diabetic (A1c\<6.5%), fasting glucose \<126mg/dl and OGTT after 2 hr \<200mg/dl)
  5. * Stable hormone treatment (estrogen or testosterone) for at least 6 months
  1. * History of or newly diagnosed diabetes mellitus
  2. * For healthy volunteers, not current treatment with estrogen or testosterone
  3. * For FTM transgender, no recent cardiovascular event: acute coronary syndrome (ACS), stroke (CVA)
  4. * For MTF and FTM transgender, less than 6 months of stable hormone treatment
  5. * Anemia with hemoglobin (Hb) \<11.0 hematocrit (Hto) \< 34 and Glomerular Filtration rate (GFR) \<30

Contacts and Locations

Principal Investigator

Devjit Tripathy, MD
PRINCIPAL_INVESTIGATOR
University of Texas Health San Antonio

Study Locations (Sites)

Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Devjit Tripathy, MD, PRINCIPAL_INVESTIGATOR, University of Texas Health San Antonio

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 Registration Dates

Study Start Date2020-06-17
Study Completion Date2025-03-17

Study Record Updates

Study Start Date2020-06-17
Study Completion Date2025-03-17

Terms related to this study

Additional Relevant MeSH Terms

  • Transgender Persons