Puberty Suppression and Cardiometabolic Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age9-14
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
15 transgender females (male sex assigned at birth, female gender identity) and 15 cisgender males
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: Transgender females
Group B: Cisgender males
Trial outcomes
Primary outcomes
1
Change in insulin sensitivity
Insulin sensitivity assessed by the oral minimal model
Time frame
Baseline, 6 monthsSecondary outcomes
1
Change in body composition (fat mass, fat-free mass)
Body composition measured by DXA
Time frame
Baseline, 6 months2
Change in resting metabolic rate
Resting metabolic rate assessed by indirect calorimetry
Time frame
Baseline, 6 months3
Change in endothelial function
Endothelial function assessed by brachial artery flow mediated dilation
Time frame
Baseline, 6 months4
Change in large elastic artery stiffness
Large elastic assessed by carotid ultrasound
Time frame
Baseline, 6 monthsSponsors and contacts
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Source ClinicalTrials.gov