Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

Transgender Persons Clinical Trial

Official title:

Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04515472
• Other study ID #: HSC20190415H
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 17, 2020
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Devjit Tripathy, MD
• Phone: 210-617-5300
• Email: tripathy[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transgender Persons

Intervention

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.

Locations

Country	Name	City	State
United States	Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Foundation for Advancing Veterans' Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Chronic estrogen therapy on insulin secretion	Change in GLP-1 in response to glucose	Baseline to 180 minutes
Primary	Effects of Chronic estrogen therapy on insulin sensitivity	Change in beta cell function	Baseline to 6 months
Primary	Effects of Chronic testosterone therapy on insulin secretion	Change in GLP-1 in response to glucose	Baseline to 180 minutes
Primary	Effects of Chronic testosterone therapy on insulin sensitivity	Change in beta cell function	Baseline to 6 months
Secondary	Immune response change	Withhold GAHT for 2 weeks after Botnia Clamp	Baseline to 6 months