Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System

Launched by UNIVERSITY OF LEIPZIG · Apr 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of cross-sex hormone therapy on several important areas of health for transgender individuals. The researchers want to understand how these hormones impact eating behaviors, metabolism (how our body uses energy), and the cardiovascular system (which includes the heart and blood vessels). By looking at these connections, the study aims to gather new insights that could help identify reasons why some people may experience issues like overeating, obesity, or heart problems while undergoing hormone therapy.

To participate in the study, individuals must be transgender patients who are already receiving hormone therapy or are considering it. They should be able to give informed consent, and if they are under 18, parental consent is required. Participants will need to have stable weight and a specific body mass index (BMI) to qualify. Throughout the study, participants will not undergo any invasive procedures, and their existing hormone treatments will continue as usual. The researchers will also explore the role of gut bacteria and other factors related to metabolism and eating behavior, which could provide a more complete picture of health during hormone therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.)