Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System

NCT04838249 | Recruiting

• 1 other identifier: 023/20-ek
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Transsexualism; Transgenderism; Adiposity; Eating Behavior; Arterial Stiffness; Microangiopathy

Keywords

Transsexualism; Energy expenditure; Energy balance; Eating behavior; Adiposity; Cardiovascular disease

Outcome Measures

Primary Outcomes (5)

• Energy expenditure

  To examine short-term and longer-term effects of cross-sex hormone therapy on changes in resting energy expenditure (kcal/d).

  up to one year

• 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).

  up to five years

• 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).

  up to five years

• 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).

  up to one year

• Weight change

  To examine short-term and longer-term effects of cross-sex hormone therapy on weight change (change from baseline in kg).

  up to one year

Secondary Outcomes (3)

• Taste perception

  up to five years

• Olfaction

  up to five years

• Gut, oral and circulating microbiomes and metabolomes

  up to five years

Study Arms (4)

Female Control

n = 20; Inclusion criteria 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.) only for part B (patients will participate in all other study parts): Insufficiently controlled endocrine disorders Chronic pulmonary disorders Diagnosed gastrointestinal diseases History of HIV infection or ongoing chronic infection 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.)

Male Control

n = 20; Inclusion criteria 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.) only for part B (patients will participate in all other study parts): Insufficiently controlled endocrine disorders Chronic pulmonary disorders Diagnosed gastrointestinal diseases History of HIV infection or ongoing chronic infection 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.)

Female cross-sex hormone therapy

n = 20; Inclusion criteria transsexual patients undergoing cross-sex hormone therapy 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, 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 Chronic pulmonary disorders Diagnosed gastrointestinal diseases History of HIV infection or ongoing chronic infection only for part D (patients will participate in all other study parts): Contraindication against performance of an MRI scan

Male cross-sex hormone therapy

n = 20; Inclusion criteria transsexual patients undergoing cross-sex hormone therapy 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, 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 Chronic pulmonary disorders Diagnosed gastrointestinal diseases History of HIV infection or ongoing chronic infection only for part D (patients will participate in all other study parts): Contraindication against performance of an MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Leipzig: lead
• Göteborg University: collaborator

Study Sites (1)

Helmholtz Institute for Metabolic, Obesity and Vascular Research

Leipzig, Saxony, 04103, Germany

RECRUITING

Related Publications (34)

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Biospecimen

Retention: SAMPLES WITH DNA

blood samples, hair

MeSH Terms

Conditions

Transsexualism; Obesity; Feeding Behavior; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal

Study Officials

• Matthias Blueher, MD

  Helmholtz Institute for Metabolic, Obesity and Vascular Research

  STUDY CHAIR

Central Study Contacts

Haiko Schloegl, MD

CONTACT

004934197; haiko.schloegl@medizin.uni-leipzig.de

Sascha Heinitz, MD

CONTACT

004934197; sascha.heinitz@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 9, 2021
• Study Start: May 5, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Up to two years post termination of recruitment.
• Access Criteria: Personal and reasonable request.

Locations

DE (1)