Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
Stopped early · Early Phase 1
Conditions studied: Transgender Persons
In brief
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
Key facts
- Study ID
- NCT04515472
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 24
- Starts
- 2020-06-17
- Expected to finish
- 2025-03-17
- Last updated by the study team
- 2025-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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