Status:
TERMINATED
Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Foundation for Advancing Veterans' Health Research
Conditions:
Transgender Persons
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 wit...
Detailed Description
All subjects will participate in a 2-hour oral glucose tolerance test (OGTT) and DXA scan for estimation of lean body mass. Only the transgender subjects will have a repeat OGTT two weeks after discon...
Eligibility Criteria
Inclusion
- Healthy volunteers: healthy male or female
- MTF transgender
- FTM transgender
- Non-diabetic (A1c\<6.5%), fasting glucose \<126mg/dl and OGTT after 2 hr \<200mg/dl)
- Stable hormone treatment (estrogen or testosterone) for at least 6 months
Exclusion
- History of or newly diagnosed diabetes mellitus
- For healthy volunteers, not current treatment with estrogen or testosterone
- For FTM transgender, no recent cardiovascular event: acute coronary syndrome (ACS), stroke (CVA)
- For MTF and FTM transgender, less than 6 months of stable hormone treatment
- Anemia with hemoglobin (Hb) \<11.0 hematocrit (Hto) \< 34 and Glomerular Filtration rate (GFR) \<30
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04515472
Start Date
June 17 2020
End Date
March 17 2025
Last Update
July 20 2025
Active Locations (1)
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1
Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS
San Antonio, Texas, United States, 78229