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Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

NCT04515472 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-20

No results posted yet for this study

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

Conditions

  • Transgender Persons

Interventions

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

Withdrawal of Gender Affirming Hormone Therapy (GAHT)

GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.

Sponsors & Collaborators

  • Foundation for Advancing Veterans' Health Research

    collaborator OTHER

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Devjit Tripathy, MD · University of Texas Health San Antonio

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2025-03-17
Completion
2025-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515472 on ClinicalTrials.gov