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Hormone Therapy's hidden effects: new study eyes metabolism and heart risks

NCT ID NCT04838249

Knowledge-focused Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observes 80 transgender individuals starting cross-sex hormone therapy (testosterone or estrogen) to see how it changes eating behavior, metabolism, weight, and heart health. Participants are followed over time with no extra treatments or procedures. The goal is to understand how sex hormones influence the body, which could help prevent obesity, diabetes, and heart disease in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
testosterone and estradiol/antiandrogens
What this could lead to
If successful, this study could reveal how sex hormones influence weight, metabolism, and heart disease risk, potentially improving long-term care for transgender individuals.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not apply to all populations, and the small size (80 participants) limits generalizability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Feeding Behavior Obesity obesity disorder thrombotic microangiopathy Transsexualism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adiposity Arterial stiffness Eating behavior Microangiopathy Transgenderism Transsexualism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Helmholtz Institute for Metabolic, Obesity and Vascular Research

    RECRUITING

    Leipzig, Saxony, 04103, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.