Transgender Persons
Conditions
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 with worsening insulin sensitivity and beta cell function 3. whether estrogen therapy leads to enhanced immune response in older transwormen
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 discontinuation of Gender Affirming Hormone Therapy (GAHT). Beta cell function will be correlated with the Estrogen/Testosterone ratio to evaluate the relationship between sex hormones and beta cell function. Plasma Glucagon-like peptide 1 (GLP-1) response during the OGTT will be measured to evaluate if estrogen treatment modulates insulin secretion by increasing GLP-1 secretion.
Interventions
DRUGBotnia Clamp
This clamp technique is designed to obtain independent measures of insulin secretion and insulin sensitivity during the same test. In brief, 0.3g/kg body wt of a 20% glucose solution is given at time 0. Blood samples for the measurement of plasma glucose and serum insulin are obtained at -10, 0, 2, 4, 6, 8, 10, 20, 30, 40, 50, 60, 120, and 180 min.
OTHERWithdrawal of Gender Affirming Hormone Therapy (GAHT)
GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.
Sponsors
Foundation for Advancing Veterans' Health Research
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
MTF and FTM non-diabetic transsexuals will be compared to healthy female and male subjects respectively.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Chronic estrogen therapy on insulin secretion | Baseline to 180 minutes | Change in GLP-1 in response to glucose |
| Effects of Chronic estrogen therapy on insulin sensitivity | Baseline to 6 months | Change in beta cell function |
| Effects of Chronic testosterone therapy on insulin secretion | Baseline to 180 minutes | Change in GLP-1 in response to glucose |
| Effects of Chronic testosterone therapy on insulin sensitivity | Baseline to 6 months | Change in beta cell function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune response change | Baseline to 6 months | Withhold GAHT for 2 weeks after Botnia Clamp |
Countries
United States
Outcome results
None listed