Status:
RECRUITING
Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
Göteborg University
Conditions:
Transsexualism
Transgenderism
Eligibility:
All Genders
18+ years
Brief Summary
Current study aims to characterize five highly interconnected physiological systems in patients undergoing cross-sex hormone therapy - namely glucose and lipid metabolism, energy balance, eating behav...
Detailed Description
1. Introduction 1.1. Transsexualism Transsexualism is a condition in which an individual's gender identity is incongruent with the assigned sex at birth. Many transsexuals suffer from severe psycholog...
Eligibility Criteria
Inclusion
- transsexual patients undergoing cross-sex hormone therapy versus controls
- able to give informed consent, if \<18 years from all legal guardians
- only for part B (patients will participate in all other study parts): weight stable (± 5%) for last 3 months, BMI ≤ 30 kg/m2
Exclusion
- severe medical impairments (e.g., uncontrolled cardiovascular disease, severe heart failure, uncontrolled hypertension, cerebral insult, active malign disease, etc.)
- self-initiated cross-sex hormone therapy before study start only for part B (patients will participate in all other study parts): Insufficiently controlled endocrine disorders (Cushing's disease, other uncontrolled pituitary disorders, uncontrolled hypothyroidism, hyperthyroidism, etc.)
- Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only will be allowed to enter the study (provided use of these agents is not required for 1 week before
- Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study entry).
- History of HIV infection or ongoing chronic infection (such as tuberculosis)
- only for part D (patients will participate in all other study parts): Contraindication against performance of an MRI scan (i.e., presence of metal in body, tattoos in head/neck region, claustrophobia etc.)
Key Trial Info
Start Date :
May 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04838249
Start Date
May 5 2021
End Date
May 1 2026
Last Update
December 5 2025
Active Locations (1)
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1
Helmholtz Institute for Metabolic, Obesity and Vascular Research
Leipzig, Saxony, Germany, 04103