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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

Condition

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)

Arm Groups

ArmDescriptionAssigned Intervention
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
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
MTF group 		MTF transgender currently on 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
  • Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)
    GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.
Active Comparator
FTM group 		FTM transgender group currently on 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
  • Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)
    GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.

Recruiting Locations

Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS
San Antonio, Texas 78229
Contact:
Devjit Tripathy, MD
210-617-5300
tripathy@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Devjit Tripathy, MD
210-617-5300
tripathy@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.