Effects of cross-sex hormone therapy on metabolism and eating behavior

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.