Transgender PersonsEarly Phase 1NCT04515472
Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
A Early Phase 1 study testing Botnia Clamp and Withdrawal of Gender Affirming Hormone Therapy (GAHT) in people with Transgender Persons, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transgender Persons
- What is being tested?
- Botnia Clamp and Withdrawal of Gender Affirming Hormone Therapy (GAHT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2020to 17 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bartter Clinical Research Unit, Audie L. Murphy VA Hospital, sTXVHCS
San Antonio, Texas, 78229
About this study
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
Read the 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.
- Conditions
- Transgender Persons
- Being tested
- Botnia Clamp, Withdrawal of Gender Affirming Hormone Therapy (GAHT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botnia ClampDrug
Also called Glucose solution and insulin
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.
Withdrawal of Gender Affirming Hormone Therapy (GAHT)Other
GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer Male | Active comparator | Healthy male currently on no testosterone treatment Receives: Drug: Botnia Clamp |
| Healthy Volunteer Female | Active comparator | Healthy female currently on no estrogen treatment Receives: Drug: Botnia Clamp |
| MTF group | Active comparator | MTF transgender currently on estrogen treatment Receives: Drug: Botnia Clamp; Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT) |
| FTM group | Active comparator | FTM transgender group currently on testosterone treatment Receives: Drug: Botnia Clamp; Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Chronic estrogen therapy on insulin secretion
Change in GLP-1 in response to glucose
Measured: Baseline to 180 minutes
Effects of Chronic estrogen therapy on insulin sensitivity
Change in beta cell function
Measured: Baseline to 6 months
Effects of Chronic testosterone therapy on insulin secretion
Change in GLP-1 in response to glucose
Measured: Baseline to 180 minutes
Effects of Chronic testosterone therapy on insulin sensitivity
Change in beta cell function
Measured: Baseline to 6 months
Secondary outcomes (1)
Immune response change
Withhold GAHT for 2 weeks after Botnia Clamp
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start17 Jun 2020
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Why it stopped: VA policy released 3/17/25 to phase out treatment for gender dysphoria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender PersonsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- MTF and FTM non-diabetic transsexuals will be compared to healthy female and male subjects respectively.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Advancing Veterans' Health Research
- Responsible party
- Sponsor
- Investigators
- Devjit Tripathy, MD, Principal investigator, University of Texas Health San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515472
- Sponsor's protocol ID
- HSC20190415H
- Status last verified
- Jul 2025
- First submitted
- 13 Aug 2020
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT04515472
- Acronym / sponsor ID
- HSC20190415H
- Conditions
- Transgender Persons
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: VA policy released 3/17/25 to phase out treatment for gender dysphoria
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Foundation for Advancing Veterans' Health Research
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- MTF and FTM non-diabetic transsexuals will be compared to healthy female and male subjects respectively.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer Male | Active comparator | Drug: Botnia ClampHealthy male currently on no testosterone treatment |
| Healthy Volunteer Female | Active comparator | Drug: Botnia ClampHealthy female currently on no estrogen treatment |
| MTF group | Active comparator | Drug: Botnia Clamp, Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)MTF transgender currently on estrogen treatment |
| FTM group | Active comparator | Drug: Botnia Clamp, Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)FTM transgender group currently on testosterone treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botnia ClampAlso: Glucose solution and insulinThis 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. | Drug | FTM group, Healthy Volunteer Female, Healthy Volunteer Male, MTF group |
| Withdrawal of Gender Affirming Hormone Therapy (GAHT)GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp. | Other | FTM group, MTF group |
Primary outcome
Effects of Chronic estrogen therapy on insulin secretion
Time frame: Baseline to 180 minutes
Change in GLP-1 in response to glucose
Effects of Chronic estrogen therapy on insulin sensitivity
Time frame: Baseline to 6 months
Change in beta cell function
Effects of Chronic testosterone therapy on insulin secretion
Time frame: Baseline to 180 minutes
Change in GLP-1 in response to glucose
Effects of Chronic testosterone therapy on insulin sensitivity
Time frame: Baseline to 6 months
Change in beta cell function
1 secondary outcome
Immune response change
Time frame: Baseline to 6 months
Results and safety
The study was stopped early (reason given: VA policy released 3/17/25 to phase out treatment for gender dysphoria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devjit Tripathy, MD principal investigator
University of Texas Health San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Botnia Clamp and Withdrawal of Gender Affirming Hormone Therapy (GAHT) in people with Transgender Persons, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: VA policy released 3/17/25 to phase out treatment for gender dysphoria). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Chronic estrogen therapy on insulin secretion (time frame: Baseline to 180 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.