Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leipzig
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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).
Trial population
Transsexual patients will be recruited in the outpatient clinic for Endocrinology at the University Hospital Leipzig. Patients seeking cross-sex hormone therapy will be asked before starting cross-sex hormone therapy for their willingness to participate in the study. If the patients would like to participate, a screening of in- and exclusion criteria will be performed. If the patient matches the criteria, the patient will be informed about the study procedures and eventual risks and if written consent will be given, the patient will be included into the study. Willingness to participate in the study will not influence the medical treatment. A control group of men and women matched for age, body mass index, health status and education who are nor undergoing cross-sex hormone therapy will be recruited through advertisements in the internet.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 4 trial groupsGroup A: Female Control
Group B: Male Control
Group C: Female cross-sex hormone therapy
Group D: Male cross-sex hormone therapy
Trial outcomes
Primary outcomes
1
Energy expenditure
To examine short-term and longer-term effects of cross-sex hormone therapy on changes in resting energy expenditure (kcal/d).
Time frame
up to one year2
Vascular stiffness
To examine short-term and longer-term effects of cross-sex hormone therapy on changes in vascular stiffness (change from baseline using cm/s to assess arterial stiffness).
Time frame
up to five years3
Insulin sensitivity
To examine short-term and longer-term effects of cross-sex hormone therapy on changes in insulin sensitivity (change from baseline using HOMA-IR to assess insulin sensitivity).
Time frame
up to five years4
Food intake
To examine short-term and longer-term effects of cross-sex hormone therapy on changes ad libitum food intake (change from baseline in kcal).
Time frame
up to one yearSecondary outcomes
1
Taste perception
To examine short-term and longer-term effects of cross-sex hormone therapy on taste perception (change from baseline score during test assessing taste perception).
Time frame
up to five years2
Olfaction
To examine short-term and longer-term effects of cross-sex hormone therapy on olfaction (change from baseline score during test assessing taste perception).
Time frame
up to five years3
Gut, oral and circulating microbiomes and metabolomes
To examine short-term and longer-term effects of cross-sex hormone therapy on gut and oral microbiome composition (change of overall diversity, functional potential) as well as decompartmentalization effects on bacterial signature in the blood. These analyses will be coupled to metabolomics to delineate the metabolic outputs of the microbial niches and relate this system to the other studied physiological systems in the study.
Time frame
up to five yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leipzig
Lead sponsor
Göteborg University
Collaborator
Source ClinicalTrials.gov