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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04515472
Other study ID # HSC20190415H
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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