Purpose

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

Category

IRB Number
20190415HU
NCT Number
NCT04515472
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Local Recruitment Point of Contact
Susan Kaiser
susan.kaiser@va.gov

Principal Investigator
Devjit Tripathy

Regulatory Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Regulatory Point of Contact
Susan Kaiser
susan.kaiser@va.gov

Regulatory Point of Contact
Devjit Tripathy
(210) 567-6691
tripathy@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
MTF and FTM non-diabetic transsexuals will be compared to healthy female and male subjects respectively.
Primary Purpose
Basic Science
Masking
None (Open Label)
Condition
  • Transgender Persons
  • Arm Groups

    ArmDescriptionIntervention
    Active Comparator

    Healthy Volunteer Male

    Healthy male currently on no testosterone treatment
  • Drug: Botnia 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.

    Other names:

    • Glucose solution and insulin

  • Active Comparator

    MTF group

    MTF transgender currently on estrogen treatment
  • Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)

    GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.

  • Drug: Botnia 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.

    Other names:

    • Glucose solution and insulin

  • Active Comparator

    Healthy Volunteer Female

    Healthy female currently on no estrogen treatment
  • Drug: Botnia 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.

    Other names:

    • Glucose solution and insulin

  • Active Comparator

    FTM group

    FTM transgender group currently on testosterone treatment
  • Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)

    GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.

  • Drug: Botnia 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.

    Other names:

    • Glucose solution and insulin