NCT04838249 Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
| NCT ID | NCT04838249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leipzig |
| Condition | Transsexualism |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-05-05 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2021-05-05 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.)
Contact & Investigator
Matthias Blueher, MD
STUDY CHAIR
Helmholtz Institute for Metabolic, Obesity and Vascular Research
Frequently Asked Questions
Who can join the NCT04838249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Transsexualism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04838249 currently recruiting?
Yes, NCT04838249 is actively recruiting participants. Contact the research team at haiko.schloegl@medizin.uni-leipzig.de for enrollment information.
Where is the NCT04838249 trial being conducted?
This trial is being conducted at Leipzig, Germany.
Who is sponsoring the NCT04838249 clinical trial?
NCT04838249 is sponsored by University of Leipzig. The principal investigator is Matthias Blueher, MD at Helmholtz Institute for Metabolic, Obesity and Vascular Research. The trial plans to enroll 80 participants.