Gender IdentityPUBErTYNCT03557268
Pubertal Blockade and Hormone Therapy in Transgender Youth
An observational study of Gender Identity and Gender Dysphoria, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will enroll female-to-male transgender youth who are and are not on a puberty blocker (gonadotropin-releasing hormone analogue) at baseline and 1 and 12 months after starting testosterone. Read more about this study
- Who is it for?
- Ages 13 to 16 years, women only
- Conditions the study is for
- Gender Identity, Gender Dysphoria, Gender Identity Disorder in Adolescence and Adulthood
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 9 Sep 2020
- Phase
- Observational
- 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 13 to 16 years
- Women only
- Child
Study population: 16 female-to-male youth will be enrolled from 2 groups: 1) 8 female-to-male youth who have been on a gonadotropin-releasing hormone analogue for > 6 months; 2) 8 female-to-male (age-matched) youth who never received gonadotropin-releasing hormone analogue therapy.
Who may be able to join
- Identify as female-to-male
- Age 13-16 years at the time of enrollment
- If on a gonadotropin-releasing hormone analogue, > 6 months exposure
- Plan to start testosterone clinically in < 6 months.
Who cannot join
- Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
- Diabetes
- Antipsychotic medication
- Hypertension (resting BP ≥ 140/90 mm/Hg)
- Weight > 400 lbs (DXA and MRI limit)
- On estrogen and/or progesterone medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Effects of Pubertal Blockade and Hormone Therapy on Cardiometabolic Risk Markers in Transgender Adolescents
This study will enroll female-to-male transgender youth who are and are not on a puberty blocker (gonadotropin-releasing hormone analogue) at baseline and 1 and 12 months after starting testosterone. The study will evaluate markers of cardiometabolic health including: insulin sensitivity, laboratory markers, vascular health, body composition, activity/fitness, mitochondrial function and the microbiome.
Read the detailed description
There will be a total of 6 study visits: baseline A, baseline B, 1 month after starting testosterone (visit A and B) and 12 months after starting testosterone (visit A and B). No medications will be administered as a part of this study.
Visit A procedures: Physical Examination, Laboratory, and Oral Glucose Tolerance Test (OGTT) visit.
This will be conducted at Childrens Hospital Colorado (CHCO) Clinical \& Translational Research Centers (CTRC) facilities. Physical examination will include vital signs, anthropometric measurements, and breast/pubic hair staging as applicable (some subjects may have already undergone mastectomy/chest masculinizing surgery) by the PI. Subjects will fast for 8 hours prior to blood draw. Fasting blood work will be obtained, followed by an oral glucose load (75g glucola). Blood glucose and insulin concentrations will be drawn at baseline and 30, 60, 90 and 120 minutes after glucola administration. Serum will be obtained at baseline and 2 hours post-OGTT and used for bile acid and lipid metabolomic profile. The following questionnaires will be administered: REDCap Health Questionnaire, PedsQLTM 4.0 generic core questionnaire, PROMIS Pediatric Anxiety Short Form, PROMIS Pediatric Depressive Symptoms Short Form, Insomnia Severity Index, Morningness and Eveningness Scale. Participants will be mailed or emailed the 3-day dietary log prior to the visit and return it at this visit. They will be given a stool microbiome collection kit and urine collection kit to return at visit B. The medical chart will be reviewed for relevant health information and medications.
Part B: Vascular Imaging, MR-based imaging and spectroscopy, Exercise Capacity and Dual-energy X-ray (DXA) visit.
This will be conducted at the University of Colorado Denver Energy Balance Core and UCD Brain Imaging Center. The participant will be fasting for a minimum of 4 hours prior to the beginning of the study visit. The investigators will perform the tests in the following order:
- Participants will return stool microbiome and urine collection kit.
- Vascular imaging: carotid artery stiffness and intimal medial thickness and brachial artery flow-mediated dilation
- Magnetic Resonance (MR) based imaging and spectroscopy
- Oxygen consumption (VO2) peak exercise test on a stationary bicycle.
- Total body dual energy x-ray absorptiometry (DXA)
- Participants will be provided with an accelerometer and actigraphy watch to wear for a period of 7 days to measure level of habitual physical activity and sleep, respectively. They will also be provided a handout with instructions and a sleep and activity diary to be filled out each day during the 7 days of wear.
- Medical subject headings
- Gender Dysphoria
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 |
|---|---|---|
| On a GnRHa | Half of subjects will be on a puberty blocker or gonadotropin-releasing hormone analogue | |
| Not on GnRHa | Half of subjects will NOT be on a puberty blocker or gonadotropin-releasing hormone analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin sensitivity
Assessed by the Matsuda index, calculated from a 2-hour oral glucose tolerance test
Measured: Baseline and 12 months after initiation of testosterone.
Change in Vascular Health
Brachial artery flow-mediated dilation
Measured: Baseline and 12 months after initiation of testosterone.
Secondary outcomes (3)
Change in Mitochondrial function
Hepatic mitochondrial function as assessed by 31Phosphorus- Magnetic Resonance Spectroscopy
Measured: Baseline and 12 months after initiation of testosterone.
Change in VO2 peak
VO2 peak as measured on a bicycle ergometer
Measured: Baseline and 12 months after initiation of testosterone.
Change in Body composition
as measured on a Dual-energy X-ray Absorptiometry (DXA) scan
Measured: Baseline and 12 months after initiation of testosterone.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start19 Jun 2018
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender IdentityStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie J Nokoff, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557268
- Sponsor's protocol ID
- 17-2328
- Acronym
- PUBErTY
- Status last verified
- Sep 2020
- First submitted
- 8 May 2018
- Last updated
- 29 Sep 2020
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pubertal Blockade and Hormone Therapy on Cardiometabolic Risk Markers in Transgender Adolescents
- ClinicalTrials.gov ID
- NCT03557268
- Acronym / sponsor ID
- PUBErTY / 17-2328
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 14 Jun 2018 (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 study will enroll female-to-male transgender youth who are and are not on a puberty blocker (gonadotropin-releasing hormone analogue) at baseline and 1 and 12 months after starting testosterone. The study will evaluate markers of cardiometabolic health including: insulin sensitivity, laboratory markers, vascular health, body composition, activity/fitness, mitochondrial function and the microbiome.
Detailed description
There will be a total of 6 study visits: baseline A, baseline B, 1 month after starting testosterone (visit A and B) and 12 months after starting testosterone (visit A and B). No medications will be administered as a part of this study.
Visit A procedures: Physical Examination, Laboratory, and Oral Glucose Tolerance Test (OGTT) visit.
This will be conducted at Childrens Hospital Colorado (CHCO) Clinical \& Translational Research Centers (CTRC) facilities. Physical examination will include vital signs, anthropometric measurements, and breast/pubic hair staging as applicable (some subjects may have already undergone mastectomy/chest masculinizing surgery) by the PI. Subjects will fast for 8 hours prior to blood draw. Fasting blood work will be obtained, followed by an oral glucose load (75g glucola). Blood glucose and insulin concentrations will be drawn at baseline and 30, 60, 90 and 120 minutes after glucola administration. Serum will be obtained at baseline and 2 hours post-OGTT and used for bile acid and lipid metabolomic profile. The following questionnaires will be administered: REDCap Health Questionnaire, PedsQLTM 4.0 generic core questionnaire, PROMIS Pediatric Anxiety Short Form, PROMIS Pediatric Depressive Symptoms Short Form, Insomnia Severity Index, Morningness and Eveningness Scale. Participants will be mailed or emailed the 3-day dietary log prior to the visit and return it at this visit. They will be given a stool microbiome collection kit and urine collection kit to return at visit B. The medical chart will be reviewed for relevant health information and medications.
Part B: Vascular Imaging, MR-based imaging and spectroscopy, Exercise Capacity and Dual-energy X-ray (DXA) visit.
This will be conducted at the University of Colorado Denver Energy Balance Core and UCD Brain Imaging Center. The participant will be fasting for a minimum of 4 hours prior to the beginning of the study visit. The investigators will perform the tests in the following order:
- Participants will return stool microbiome and urine collection kit.
- Vascular imaging: carotid artery stiffness and intimal medial thickness and brachial artery flow-mediated dilation
- Magnetic Resonance (MR) based imaging and spectroscopy
- Oxygen consumption (VO2) peak exercise test on a stationary bicycle.
- Total body dual energy x-ray absorptiometry (DXA)
- Participants will be provided with an accelerometer and actigraphy watch to wear for a period of 7 days to measure level of habitual physical activity and sleep, respectively. They will also be provided a handout with instructions and a sleep and activity diary to be filled out each day during the 7 days of wear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On a GnRHa | – | –Half of subjects will be on a puberty blocker or gonadotropin-releasing hormone analogue |
| Not on GnRHa | – | –Half of subjects will NOT be on a puberty blocker or gonadotropin-releasing hormone analogue |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- Female only
- Age groups
- Child
- Study population
- 16 female-to-male youth will be enrolled from 2 groups: 1) 8 female-to-male youth who have been on a gonadotropin-releasing hormone analogue for > 6 months; 2) 8 female-to-male (age-matched) youth who never received gonadotropin-releasing hormone analogue therapy.
Key inclusion criteria (4 listed)
- Identify as female-to-male
- Age 13-16 years at the time of enrollment
- If on a gonadotropin-releasing hormone analogue, > 6 months exposure
- Plan to start testosterone clinically in < 6 months.
Key exclusion criteria (6 listed)
- Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
- Diabetes
- Antipsychotic medication
- Hypertension (resting BP ≥ 140/90 mm/Hg)
- Weight > 400 lbs (DXA and MRI limit)
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 and 12 months after initiation of testosterone.
Assessed by the Matsuda index, calculated from a 2-hour oral glucose tolerance test
Change in Vascular Health
Time frame: Baseline and 12 months after initiation of testosterone.
Brachial artery flow-mediated dilation
3 secondary outcomes
Change in Mitochondrial function
Time frame: Baseline and 12 months after initiation of testosterone.
Change in VO2 peak
Time frame: Baseline and 12 months after initiation of testosterone.
Change in Body composition
Time frame: Baseline and 12 months after initiation of testosterone.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- 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. This study is not recruiting at the moment.
Natalie J Nokoff, MD 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 Gender Identity and Gender Dysphoria, 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 6 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: finished, as of the sponsor's last update on 29 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Insulin sensitivity (time frame: Baseline and 12 months after initiation of testosterone.). The study lists 2 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 29 Sep 2020.