Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

Early Phase 1TerminatedNCT04515472

The University of Texas Health Science Center at San Antonio24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Transgender Persons

Interventions

Botnia ClampDRUG

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.

Withdrawal of Gender Affirming Hormone Therapy (GAHT)OTHER

GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Effects of Chronic estrogen therapy on insulin secretion

Change in GLP-1 in response to glucose

Time frame: Baseline to 180 minutes

Effects of Chronic estrogen therapy on insulin sensitivity

Change in beta cell function

Time frame: Baseline to 6 months

Effects of Chronic testosterone therapy on insulin secretion

Change in GLP-1 in response to glucose

Time frame: Baseline to 180 minutes

Effects of Chronic testosterone therapy on insulin sensitivity

Change in beta cell function

Time frame: Baseline to 6 months

Secondary Outcomes

Immune response change

Withhold GAHT for 2 weeks after Botnia Clamp

Time frame: Baseline to 6 months

Data from ClinicalTrials.gov

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