Actively Recruiting
Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Led by University of Leipzig · Updated on 2025-12-05
80
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University of Leipzig
Lead Sponsor
G
Göteborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transsexual patients undergoing cross-sex hormone therapy or controls
- Able to give informed consent; if under 18 years, consent from all legal guardians
- For body composition and energy balance part: weight stable (±5%) for last 3 months and BMI ≤ 30 kg/m²
You will not qualify if you...
- Severe medical impairments such as uncontrolled cardiovascular disease, severe heart failure, uncontrolled hypertension, stroke, or active cancer
- Self-initiated cross-sex hormone therapy before study start (for body composition and energy balance part)
- Uncontrolled endocrine disorders like Cushing's disease, pituitary disorders, hypothyroidism, or hyperthyroidism
- Chronic lung diseases limiting protocol adherence, except mild or exercise-induced asthma on limited medication
- Diagnosed gastrointestinal diseases including inflammatory bowel disease, malabsorption syndromes, or active gastric ulcer
- History of HIV or ongoing chronic infections like tuberculosis
- Contraindications for MRI scan (for cardiovascular part), such as metal in body, tattoos on head/neck, or claustrophobia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Helmholtz Institute for Metabolic, Obesity and Vascular Research
Leipzig, Saxony, Germany, 04103
Actively Recruiting
Research Team
H
Haiko Schloegl, MD
CONTACT
S
Sascha Heinitz, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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