- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515472
Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
The study will test:
- whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function
- whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function
- whether estrogen therapy leads to enhanced immune response in older transwormen
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Devjit Tripathy, MD
- Phone Number: 17822 210-617-5300
- Email: tripathy@uthscsa.edu
Study Contact Backup
- Name: Emina Case
- Phone Number: 17822 210-617-5300
- Email: morinae@uthscsa.edu
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Recruiting
- Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS
-
Contact:
- Devjit Tripathy, MD
- Phone Number: 17822 210-617-5300
- Email: tripathy@uthscsa.edu
-
Contact:
- Emina Case
- Phone Number: 17822 210-617-5300
- Email: morinae@uthscsa.edu
-
Principal Investigator:
- Devjit Tripathy, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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:
|
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:
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:
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
Collaborators
Investigators
- Principal Investigator: Devjit Tripathy, MD, University of Texas Health San Antonio
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20190415H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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