Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
Overview
- Phase
- Early Phase 1
- Intervention
- Botnia Clamp
- Conditions
- Transgender Persons
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Effects of Chronic estrogen therapy on insulin secretion
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
Brief Summary
The study will test:
- whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function
- whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function
- 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.
Investigators
Eligibility 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
Arms & Interventions
Healthy Volunteer Male
Healthy male currently on no testosterone treatment
Intervention: Botnia Clamp
Healthy Volunteer Female
Healthy female currently on no estrogen treatment
Intervention: Botnia Clamp
MTF group
MTF transgender currently on estrogen treatment
Intervention: Botnia Clamp
MTF group
MTF transgender currently on estrogen treatment
Intervention: Withdrawal of Gender Affirming Hormone Therapy (GAHT)
FTM group
FTM transgender group currently on testosterone treatment
Intervention: Botnia Clamp
FTM group
FTM transgender group currently on testosterone treatment
Intervention: Withdrawal of Gender Affirming Hormone Therapy (GAHT)
Outcomes
Primary Outcomes
Effects of Chronic estrogen therapy on insulin secretion
Time Frame: Baseline to 180 minutes
Change in GLP-1 in response to glucose
Effects of Chronic testosterone therapy on insulin secretion
Time Frame: Baseline to 180 minutes
Change in GLP-1 in response to glucose
Effects of Chronic estrogen therapy on insulin sensitivity
Time Frame: Baseline to 6 months
Change in beta cell function
Effects of Chronic testosterone therapy on insulin sensitivity
Time Frame: Baseline to 6 months
Change in beta cell function
Secondary Outcomes
- Immune response change(Baseline to 6 months)