Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Effects of GAHT, on Skeletal Muscle in TGD
- Sponsor
- Mayo Clinic
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Aim 1
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
The primary purpose of this research is to determine how gender affirming hormone therapy affects muscle physiology.
Detailed Description
Study participation involves a screening visit and two study visits. The screen includes blood draws, and urine testing. The first visit requires a collection of breath, exercise testing, and body scans. Between visits participant are to eat three days of provided meals and wear an activity monitor. The second study visit will be 3-14 days after the first and includes blood draws, a meal test, and a muscle biopsy. If individuals are not on gender affirming hormone therapy at the time of participation, they may be able to participate again if you decide to pursue gender affirming hormone therapy later on.
Investigators
K. Sreekumaran Nair
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •age 18-40yrs
- •BMI 18.5-38 kg/m2
- •Fasting glucose \< 100 mg/dL
- •No gender affirming gonadal surgery
- •We seek to enroll 6 patients in each group who have been on GAHT for more than 10 months with minimal interruptions in treatment.
Exclusion Criteria
- •Pregnancy
- •Use of hormonal forms of birth control within the previous 3 months
- •Use of glucocorticoids, estradiol, testosterone, progestin, antiandrogens, or antiestrogens besides those received as part of a supervised hormone therapy.
- •Gender-affirming gonadal surgery
- •Prior use of gonadotropin releasing hormone (GnRH) analogues during puberty
- •Coronary artery disease or heart failure.
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- •Inpatient psychiatric treatment in the past 6 months
- •Presence of a known adrenal disorder
- •Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
Outcomes
Primary Outcomes
Aim 1
Time Frame: 2 weeks
To identify the impact of gender-affirming hormone therapy (GAHT) on skeletal muscle mitochondrial metabolism in transgender and gender diverse individuals.
Secondary Outcomes
- Aim 2(2 weeks)