Effects of cross-sex hormone therapy on metabolism and eating behavior
Investigation of the Effects of Testosterone and Estrogen on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System in Transsexual Patients Undergoing Cross-sex Hormone Therapy
This study looks at how cross-sex hormone therapy affects metabolism, eating habits, and overall health in people undergoing this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 1 site (Leipzig, Saxony) |
| Trial ID | NCT04838249 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the interconnected physiological systems in patients undergoing cross-sex hormone therapy, focusing on glucose and lipid metabolism, energy balance, eating behavior, and cardiovascular health. It seeks to gather insights into how sex hormones influence these systems and their potential role in overeating, obesity, insulin resistance, and cardiovascular disease. Additionally, the study will investigate the relationships between gut and oral microbiomes and their impact on these physiological systems.
Who should consider this trial
Good fit: Ideal candidates for this study are transsexual patients undergoing cross-sex hormone therapy who are weight stable and have a BMI of 30 kg/m2 or less.
Not a fit: Patients with severe medical impairments or those who have self-initiated cross-sex hormone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the health impacts of cross-sex hormone therapy, potentially improving treatment strategies for transgender individuals.
How similar studies have performed: While there is limited data on the specific effects of cross-sex hormone therapy on these physiological systems, similar studies have shown promising results in understanding hormonal impacts on metabolism and cardiovascular health.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Leipzig, Saxony
- Helmholtz Institute for Metabolic, Obesity and Vascular Research — Leipzig, Saxony, Germany (Recruiting)
Study contacts
- Study coordinator: Haiko Schloegl, MD
- Email: haiko.schloegl@medizin.uni-leipzig.de
- Phone: 004934197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.