Clinical trial NCT04515472: Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
Official title: Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Transgender Persons
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Foundation for Advancing Veterans' Health Research
First posted: 2020-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: MTF and FTM non-diabetic transsexuals will be compared to healthy female and male subjects respectively.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Effects of Chronic estrogen therapy on insulin secretion
timeFrame: Baseline to 180 minutes
measure: Effects of Chronic estrogen therapy on insulin sensitivity
timeFrame: Baseline to 6 months
measure: Effects of Chronic testosterone therapy on insulin secretion
timeFrame: Baseline to 180 minutes
measure: Effects of Chronic testosterone therapy on insulin sensitivity
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Immune response change
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS
state: Texas
Study officials:
affiliation: University of Texas Health San Antonio
name: Devjit Tripathy, MD
role: PRINCIPAL_INVESTIGATOR
References: