Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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 with worsening insulin sensitivity and beta cell function

3. whether estrogen therapy leads to enhanced immune response in older transwormen

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: Foundation for advancing Veterans Health Research (FAVHR)
• Treatments: Hormones

Criteria

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