Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

  • STATUS
    Recruiting
  • End date
    Feb 23, 2024
  • participants needed
    60
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 23 March 2022
Accepts healthy volunteers

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

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.

Details
Condition Transgender Persons
Treatment Botnia Clamp, Withdrawal of Gender Affirming Hormone Therapy (GAHT)
Clinical Study IdentifierNCT04515472
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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