TransgenderismNCT04482374
Puberty Suppression and Cardiometabolic Health
An observational study of Transgenderism and Insulin Sensitivity/Resistance, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls. Read more about this study
- Who is it for?
- Ages 9 to 14 years, men only
- Conditions the study is for
- Transgenderism, Insulin Sensitivity/Resistance, Endothelial Dysfunction
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2020to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 9 to 14 years
- Men only
- Child
Study population: 15 transgender females (male sex assigned at birth, female gender identity) and 15 cisgender males
Who may be able to join
- Identify as a transgender female or cisgender male
- Age 9-14 years at the time of enrollment
- Tanner Stage 2-3 baseline pubertal development
- Plan to start gonadotropin releasing hormone analogue clinically in < 2 months (for transgender females only)
Who cannot join
- Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
- Type 1 or 2 diabetes (by medical history)
- On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
- Hypertension (resting BP ≥ 140/90 mm/Hg)
- Weight > 400 lbs
- On estrogen- or progesterone-containing medications at baseline
- >3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Natalie Nokoff, MD, MSCS, 720-777-3607, Natalie.Nokoff@childrenscolorado.org
About this study
Official title: Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.
- Conditions
- Transgenderism, Insulin Sensitivity/Resistance, Endothelial Dysfunction, Vascular Stiffness
- Medical subject headings
- Transsexualism, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transgender females | Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months | |
| Cisgender males | Cisgender male controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Insulin sensitivity assessed by the oral minimal model
Measured: Baseline, 6 months
Secondary outcomes (5)
Change in body composition (fat mass, fat-free mass)
Body composition measured by DXA
Measured: Baseline, 6 months
Change in resting metabolic rate
Resting metabolic rate assessed by indirect calorimetry
Measured: Baseline, 6 months
Change in endothelial function
Endothelial function assessed by brachial artery flow mediated dilation
Measured: Baseline, 6 months
Change in large elastic artery stiffness
Large elastic assessed by carotid ultrasound
Measured: Baseline, 6 months
Change in cerebrovascular function
Middle cerebral artery blood flow assessed using bilateral transcranial Doppler
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start10 Aug 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie J Nokoff, MD, MSCS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482374
- Sponsor's protocol ID
- 19-2109
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2020
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
- ClinicalTrials.gov ID
- NCT04482374
- Acronym / sponsor ID
- 19-2109
- Conditions
- Transgenderism, Insulin Sensitivity/Resistance, Endothelial Dysfunction, Vascular Stiffness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 Jul 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.
This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender females | – | –Transgender females who plan to start a gonadotropin releasing hormone agonist clinically in the next 2 months |
| Cisgender males | – | –Cisgender male controls |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Male only
- Age groups
- Child
- Study population
- 15 transgender females (male sex assigned at birth, female gender identity) and 15 cisgender males
Key inclusion criteria (4 listed)
- Identify as a transgender female or cisgender male
- Age 9-14 years at the time of enrollment
- Tanner Stage 2-3 baseline pubertal development
- Plan to start gonadotropin releasing hormone analogue clinically in < 2 months (for transgender females only)
Key exclusion criteria (7 listed)
- Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
- Type 1 or 2 diabetes (by medical history)
- On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
- Hypertension (resting BP ≥ 140/90 mm/Hg)
- Weight > 400 lbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in insulin sensitivity
Time frame: Baseline, 6 months
Insulin sensitivity assessed by the oral minimal model
5 secondary outcomes
Change in body composition (fat mass, fat-free mass)
Time frame: Baseline, 6 months
Change in resting metabolic rate
Time frame: Baseline, 6 months
Change in endothelial function
Time frame: Baseline, 6 months
Change in large elastic artery stiffness
Time frame: Baseline, 6 months
Change in cerebrovascular function
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Natalie J Nokoff, MD, MSCS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgenderism and Insulin Sensitivity/Resistance, run by University of Colorado, Denver 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Jun 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie J Nokoff, MD, MSCS (720-777-6128, natalie.nokoff@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity (time frame: Baseline, 6 months). 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 10 Jun 2025.