Actively Recruiting

Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT06083766

Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People

Led by Mayo Clinic · Updated on 2025-11-10

24

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The primary purpose of this research is to determine how gender affirming hormone therapy affects muscle physiology.

CONDITIONS

Official Title

Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 40 years
  • Body mass index (BMI) between 18.5 and 38 kg/m2
  • Fasting glucose level less than 100 mg/dL
  • No history of gender affirming gonadal surgery
  • Have been on gender affirming hormone therapy for more than 10 months with minimal interruptions
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Use of hormonal birth control in the past 3 months
  • Use of glucocorticoids, estradiol, testosterone, progestin, antiandrogens, or antiestrogens outside supervised hormone therapy
  • History of gender affirming gonadal surgery
  • Prior use of gonadotropin releasing hormone analogues during puberty
  • Coronary artery disease or heart failure
  • Recent inpatient psychiatric treatment within 6 months
  • Known adrenal disorder
  • Abnormal liver function tests (transaminase more than twice the upper limit of normal)
  • Abnormal kidney function (GFR less than 45 mL/min/1.73m2)
  • Active gastroparesis
  • Unstable medication use for antihypertensive, thyroid, antidepressant, or lipid lowering drugs in past 2 months
  • Uncontrolled thyroid disease
  • Alcohol or recreational drug abuse
  • Active infections not expected to resolve before study
  • Uncontrolled high blood pressure (diastolic >90 mmHg or systolic >160 mmHg)
  • Recent injury, muscular disorder, medications, cancer, or medical conditions that interfere with exercise testing or muscle biopsy
  • Use of medications affecting mitochondrial biology such as beta blockers
  • Use of anti-hyperglycemic drugs including metformin
  • Any other medication contraindicated by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

J

Jennifer R Hewlett, M.D.

CONTACT

R

Rose A Decker

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Metabolic and Physiologic Responses to Hormone Therapy in Transgender and Gender Diverse People | DecenTrialz