Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leipzig
About this trial
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 behavior, functional brain networks involved in the regulation of eating behavior and the cardiovascular system - to gain novel insights into the effects of sex hormones on the human body. Gathered information will help to identify pathophysiological mechanisms for the development of overeating/obesity, insulin resistance, and cardiovascular disease. Secondarily, the relationships between the gut and oral microbiomes and metabolomes and circulating bacterial signatures will be investigated in relation to the other pervasive physiological systems.
Current study is an observational study. The decision if the patient's request for cross-sex hormone therapy can complied with (i.e., if cross-sex hormone therapy is medically indicated) is made prior to the first contact with the study center and with the outpatients clinic for Endocrinology at the University Hospital in Leipzig. Decision ifor treatment is made according to national and international guidelines. Treatment of study participants with testosterone and estradiol/antiandrogens is not affected by the study. During the course of the study no invasive interventions are being performed.
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
80 Participants
are grouped into 4 trial groupsSponsors and collaborators
University of Leipzig
Lead sponsor
Göteborg University
Collaborator
Source ClinicalTrials.gov