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Lay 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

Category

  • Other
IRB Number
20190415HU
NCT Number
NCT04515472
Open to Enrollment
Yes

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 Criteria

  • 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

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Regulatory Point of Contact
Susan Kaiser
susan.kaiser@va.gov

Regulatory Point of Contact
Devjit Tripathy
(210) 567-6691
tripathy@uthscsa.edu

Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Local Recruitment Point of Contact
Susan Kaiser
susan.kaiser@va.gov

Principal Investigator
Devjit Tripathy