Sex differences in the physiology of eating.
Lori Asarian, Nori Geary
https://pubmed.ncbi.nlm.nih.gov/23904103Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID04838249
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
Led by University of Leipzig · Updated on 2025-12-05
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Leipzig
Lead Sponsor
G
Göteborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of cross-sex hormone therapy on several interconnected body systems in people undergoing this treatment for gender dysphoria. The study focuses on glucose and lipid metabolism, energy balance, eating behavior, functional brain networks related to eating, and the cardiovascular system. It also explores how the gut and oral microbiomes and metabolomes relate to these systems to better understand risks of overeating, obesity, insulin resistance, and heart disease. This observational study compares individuals starting cross-sex hormone therapy with a control group not receiving hormone treatment. Patients receive testosterone or estradiol/antiandrogens according to medical guidelines, and no invasive procedures are performed. Measurements are taken before starting therapy and at several time points over five years, including assessments at 3, 6, 12, 24, and 60 months. Controls matched by age, BMI, and health status are included for comparison. Participants undergo detailed evaluations including physical exams, blood tests, body composition analysis, energy expenditure measurement, ultrasound of vessels, food intake tests, taste and smell assessments, and microbiome sample collection. Data on hormone levels, metabolism, cardiovascular health, and eating behavior are collected repeatedly. Safety monitoring includes non-invasive procedures and questionnaires. The study aims to follow participants for up to five years to understand long-term effects of hormone therapy on these physiological systems.
CONDITIONS
Brief Title
Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Transsexual patients undergoing cross-sex hormone therapy or matched controls
- Able to give informed consent (for those under 18, consent from legal guardians required)
- For part B only: stable weight (±5%) for last 3 months
- For part B only: BMI of 30 kg/m2 or less
You will not qualify if you...
- Severe medical impairments such as uncontrolled cardiovascular disease, severe heart failure, uncontrolled hypertension, cerebral insult, or active malignancy
- Self-initiated cross-sex hormone therapy before study start
- For part B only: insufficiently controlled endocrine disorders (e.g., Cushing's disease, uncontrolled thyroid disorders)
- Chronic pulmonary disorders limiting protocol adherence (except mild asthma without recent medication)
- Diagnosed gastrointestinal diseases like inflammatory bowel disease or active gastric ulcers
- History of HIV infection or ongoing chronic infection such as tuberculosis
- For part D only: contraindications to MRI scan (e.g., metal implants, tattoos in head/neck region, claustrophobia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility and obtain informed consent
Baseline Assessment
Duration - 1 day
Participants undergo a comprehensive baseline assessment before starting cross-sex hormone therapy or no therapy, including medical history, physical examination, body composition, energy expenditure, cardiovascular ultrasound, food intake tests, sensory perception tests, and microbiome sampling.
1 visit (in-person) for baseline measurements and assessments
Cross-sex Hormone Therapy and Monitoring
Duration - Up to 5 years
Participants undergoing cross-sex hormone therapy receive hormone treatment and are monitored with repeated assessments to investigate effects on metabolism, eating behavior, energy balance, cardiovascular system, and microbiomes.
6 visits over 5 years at 3 months, 6 months, 12 months, 2 years, and 5 years after starting therapy
Control Group Monitoring
Duration - Up to 5 years
Participants not undergoing cross-sex hormone therapy are monitored with the same assessments over time to compare changes with treated participants.
6 visits over 5 years matching the treatment group schedule
Trial Site Locations
Total: 1 location
1
Helmholtz Institute for Metabolic, Obesity and Vascular Research
Leipzig, Saxony, Germany, 04103
Actively Recruiting
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Research Team
H
Haiko Schloegl, MD
S
Sascha Heinitz, MD
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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