Gender DysphoriaDysGeMetNCT04508231
Metabolic Consequences of Cross-sex Hormonal Treatment
An observational study of Gender Dysphoria, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Retrospective study in a single academic regional transgender referral center. Analyse VAT, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- Gender-affirming hormone therapy
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the out-patient clinic at our department of endocrinology
Who may be able to join
None listed.
Who cannot join
- hormonal contraception
- previous gender-affirming hormonal treatment
- previous gender-affirming surgery
- recognized syndrome or chromosomal defect, known metabolic or inflammatory disease, skeletal dysplasia, or chronic corticosteroid treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Consequences of Cross-sex Hormonal Treatment in Transgender Persons
Retrospective study in a single academic regional transgender referral center. Analyse VAT, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls
- Conditions
- Gender Dysphoria
- Being tested
- Gender-affirming hormone therapy
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gender-affirming hormone therapyOther
Gender-affirming hormone therapy according to the recommendations of the Endocrine Society
| Study group | Role | What they receive |
|---|---|---|
| Hormonal treatment | The University Hospital in Nancy is an academic regional transgender referral center in Lorraine (France) and keeps a register of subjects available from 2004. The register at the time of the present study (February 2020) included 320 subjects who met diagnostic criteria for gender dysphoria and were seen regularly in the out-patient clinic at our department of endocrinology. Our investigation is a part of the regular care of subjects with gender dysphoria. Receives: Other: Gender-affirming hormone therapy | |
| Controls | Data for control subjects are retrieved from medical records of healthy non-obese females and males who underwent an initial assessment for gender dysphoria in our department, but not yet receiving hormonal treatment at the time of the present study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of existing data collected as a part of the regular follow-up
Retrospective analysis of existing data :Anthropometric parameters, including systolic blood pressure (SBP), diastolic blood pressure (DBP), body weight and height at fasting state, were measured in all subjects at the occasion of the routine follow-up visits. Body mass index (BMI) was calculated as body weight in kilograms divided by the height in meter squared (kg/m2). Body composition parameters, including lean mass (LM), total body fat (BF), android and gynoid fat, and bone mineral content, were determined using dual-energy X-Ray absorbtiometry (DXA) (GE-Healthcare Lunar iDXA system), biochemical and routine hormonal analysis
Measured: Retrospective analysis of data between 2004 and 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start24 Jul 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508231
- Sponsor's protocol ID
- 2020PI157
- Acronym
- DysGeMet
- Status last verified
- Jul 2020
- First submitted
- 3 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Larose C, Samhani C, Consolandi P, Feigerlova E. Increase in visceral adipose tissue and altered metabolic profile in transgender men but not in transgender women one year after starting gender-affirming hormonal therapy. Endocrine. 2025 Sep;89(3):901-909. doi: 10.1007/s12020-025-04310-y. Epub 2025 Jun 10.
PubMed 40495044
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Consequences of Cross-sex Hormonal Treatment in Transgender Persons
- ClinicalTrials.gov ID
- NCT04508231
- Acronym / sponsor ID
- DysGeMet / 2020PI157
- Conditions
- Gender Dysphoria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective study in a single academic regional transgender referral center. Analyse VAT, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormonal treatment | – | Other: Gender-affirming hormone therapyThe University Hospital in Nancy is an academic regional transgender referral center in Lorraine (France) and keeps a register of subjects available from 2004. The register at the time of the present study (February 2020) included 320 subjects who met diagnostic criteria for gender dysphoria and were seen regularly in the out-patient clinic at our department of endocrinology. Our investigation is a part of the regular care of subjects with gender dysphoria. |
| Controls | – | –Data for control subjects are retrieved from medical records of healthy non-obese females and males who underwent an initial assessment for gender dysphoria in our department, but not yet receiving hormonal treatment at the time of the present study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the out-patient clinic at our department of endocrinology
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- hormonal contraception
- previous gender-affirming hormonal treatment
- previous gender-affirming surgery
- recognized syndrome or chromosomal defect, known metabolic or inflammatory disease, skeletal dysplasia, or chronic corticosteroid treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gender-affirming hormone therapyGender-affirming hormone therapy according to the recommendations of the Endocrine Society | Other | Hormonal treatment |
Primary outcome
Retrospective analysis of existing data collected as a part of the regular follow-up
Time frame: Retrospective analysis of data between 2004 and 2019
Retrospective analysis of existing data :Anthropometric parameters, including systolic blood pressure (SBP), diastolic blood pressure (DBP), body weight and height at fasting state, were measured in all subjects at the occasion of the routine follow-up visits. Body mass index (BMI) was calculated as body weight in kilograms divided by the height in meter squared (kg/m2). Body composition parameters, including lean mass (LM), total body fat (BF), android and gynoid fat, and bone mineral content, were determined using dual-energy X-Ray absorbtiometry (DXA) (GE-Healthcare Lunar iDXA system), biochemical and routine hormonal analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 40495044Larose C, Samhani C, Consolandi P, Feigerlova E. Increase in visceral adipose tissue and altered metabolic profile in transgender men but not in transgender women one year after starting gender-affirming hormonal therapy. Endocrine. 2025 Sep;89(3):901-909. doi: 10.1007/s12020-025-04310-y. Epub 2025 Jun 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of existing data collected as a part of the regular follow-up (time frame: Retrospective analysis of data between 2004 and 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.