Pubertal Blockade and Hormone Therapy in Transgender Youth (PUBErTY)
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|ClinicalTrials.gov Identifier: NCT03557268|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
|Condition or disease|
|Gender Identity Gender Dysphoria Gender Identity Disorder in Adolescence and Adulthood|
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 Type :||Observational|
|Estimated Enrollment :||16 participants|
|Official Title:||Effects of Pubertal Blockade and Hormone Therapy on Cardiometabolic Risk Markers in Transgender Adolescents|
|Estimated Study Start Date :||June 19, 2018|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2020|
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
- 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
- Change in Mitochondrial function [ Time Frame: Baseline and 12 months after initiation of testosterone. ]Hepatic mitochondrial function as assessed by 31Phosphorus- Magnetic Resonance Spectroscopy
- Change in VO2 peak [ Time Frame: Baseline and 12 months after initiation of testosterone. ]VO2 peak as measured on a bicycle ergometer
- Change in Body composition [ Time Frame: Baseline and 12 months after initiation of testosterone. ]as measured on a Dual-energy X-ray Absorptiometry (DXA) scan
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557268
|Contact: Natalie J Nokoff, MD||720-777-3607||Natalie.Nokoff@childrenscolorado.org|
|Contact: Susan Staggs, BS||720-777-6128||Susan.Staggs@childrenscolorado.org|
|Principal Investigator:||Natalie J Nokoff, MD||University of Colorado, Denver|