Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

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

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS
        • Contact:
        • Contact:
        • Principal Investigator:
          • Devjit Tripathy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Volunteer Male
Healthy male currently on no testosterone treatment
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
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
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
GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.
Active Comparator: FTM group
FTM transgender group currently on testosterone treatment
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
GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Chronic estrogen therapy on insulin secretion
Time Frame: Baseline to 180 minutes
Change in GLP-1 in response to glucose
Baseline to 180 minutes
Effects of Chronic estrogen therapy on insulin sensitivity
Time Frame: Baseline to 6 months
Change in beta cell function
Baseline to 6 months
Effects of Chronic testosterone therapy on insulin secretion
Time Frame: Baseline to 180 minutes
Change in GLP-1 in response to glucose
Baseline to 180 minutes
Effects of Chronic testosterone therapy on insulin sensitivity
Time Frame: Baseline to 6 months
Change in beta cell function
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response change
Time Frame: Baseline to 6 months
Withhold GAHT for 2 weeks after Botnia Clamp
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Devjit Tripathy, MD, University of Texas Health San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HSC20190415H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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