TransgenderismNCT05728853
Is Bioimpedance Analysis Accurate in Transgender Males?
An observational study of Transgenderism, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Accurate fat mass and muscle mass assessment is an informative marker of an individual's health. However, the optimal method for assessing body composition in transgender males remains to be determined. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Transgenderism
- What is being tested?
- Assessment of body composition
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Apr 2023to 3 May 2023
- 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 to 80 years
- Women only
- Adult, Older adult
Study population: Transgender males in hormonal therapy
Who may be able to join
- Trans gender males in hormonal therapy
- Age ≥ 18 years
- Ability to provide informed consent
Who cannot join
- Inability to comprehend written consent form or provide informed consent
- BMI > 35
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Accurate fat mass and muscle mass assessment is an informative marker of an individual's health. However, the optimal method for assessing body composition in transgender males remains to be determined. Here, the investigators aim to compare body composition estimates in transgender males by bioimpedance analysis using the reference settings for males and females and by
Read the detailed description
Gender incongruence is defined as a condition in which the gender with which a person identifies does not align with the gender assigned at birth. According to a recent population survey, 0.55% of the Danish population are gender incongruent, and 0.10% define themselves as transgender. There is an equal distribution between trans men and trans women. The treatments include gender-affirming hormone therapy and gender-affirming surgery. Exogenous treatment with sex steroids such as testosterone plays an important role in the distribution of body fat and lean body mass development, and thus induces masculinization of body composition in transgender males.
Body composition is a highly informative marker of an individual's nutrition-related condition and health. Furthermore, it contributes to the identification, diagnosis, and management of several medical conditions. In obesity, the body composition assessment improves the diagnosis and is useful in the monitoring of treatment response, which is central in the management of obesity-related chronic diseases and sarcopenic obesity. Maintaining muscle mass (MM) is important for longevity and health in humans as there is a natural increase in fat mass (FM) and a decrease in MM with age. This leads to an increased risk of cardiovascular disease, type 2 diabetes, several types of cancer, sarcopenia, and even early mortality. However, weight and BMI do not provide insights into the relative contributions of FM and MM on disease risk.
Body composition measured by bioimpedance analysis (BIA) includes FM and lean body mass estimates. The test is inexpensive, readily reproducible and suitable for outpatient clinic patients. Body fat percentage, measured by BIA, reflects body adiposity and is a superior indicator of obesity compared to BMI. Dual x-ray absorptiometry (DXA) is the gold standard distinguishing fat, lean tissue, and bone mineral, thus providing accurate estimates of bone mineral density, FM, and lean soft tissue/fat-free mass (FFM). The main limitations of DXA are that it is expensive, time-consuming, and exposes the subjects to radiation, which may hinder its use at a large scale. As body composition is more accurately assessed by fat percentage and FFM than BMI, it is relevant to consider which methods are most reliable for assessing body composition in transgender males.
We aim to investigate whether estimates of body composition by BIA in transgender males are significantly affected by the use of binary reference values. Furthermore, we aim to compare the body composition estimated by BIA to DXA scans.
- Conditions
- Transgenderism
- Being tested
- Assessment of body composition
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of body compositionRadiation
Assessment of body composition using BIA and DXA
| Study group | Role | What they receive |
|---|---|---|
| Trans gender males | Trans gender males in hormonal therapy Receives: Radiation: Assessment of body composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat percentage
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start20 Apr 2023
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Graungaard, Aalborg University Hospital
- Investigators
- Signe Graungaard, MSc, Principal investigator, North Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728853
- Sponsor's protocol ID
- N-20220054
- Status last verified
- Jan 2024
- First submitted
- 6 Feb 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Bioimpedance Analysis Accurate in Transgender Males?
- ClinicalTrials.gov ID
- NCT05728853
- Acronym / sponsor ID
- N-20220054
- Conditions
- Transgenderism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 15 Feb 2023 (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.
Accurate fat mass and muscle mass assessment is an informative marker of an individual's health. However, the optimal method for assessing body composition in transgender males remains to be determined. Here, the investigators aim to compare body composition estimates in transgender males by bioimpedance analysis using the reference settings for males and females and by
Detailed description
Gender incongruence is defined as a condition in which the gender with which a person identifies does not align with the gender assigned at birth. According to a recent population survey, 0.55% of the Danish population are gender incongruent, and 0.10% define themselves as transgender. There is an equal distribution between trans men and trans women. The treatments include gender-affirming hormone therapy and gender-affirming surgery. Exogenous treatment with sex steroids such as testosterone plays an important role in the distribution of body fat and lean body mass development, and thus induces masculinization of body composition in transgender males.
Body composition is a highly informative marker of an individual's nutrition-related condition and health. Furthermore, it contributes to the identification, diagnosis, and management of several medical conditions. In obesity, the body composition assessment improves the diagnosis and is useful in the monitoring of treatment response, which is central in the management of obesity-related chronic diseases and sarcopenic obesity. Maintaining muscle mass (MM) is important for longevity and health in humans as there is a natural increase in fat mass (FM) and a decrease in MM with age. This leads to an increased risk of cardiovascular disease, type 2 diabetes, several types of cancer, sarcopenia, and even early mortality. However, weight and BMI do not provide insights into the relative contributions of FM and MM on disease risk.
Body composition measured by bioimpedance analysis (BIA) includes FM and lean body mass estimates. The test is inexpensive, readily reproducible and suitable for outpatient clinic patients. Body fat percentage, measured by BIA, reflects body adiposity and is a superior indicator of obesity compared to BMI. Dual x-ray absorptiometry (DXA) is the gold standard distinguishing fat, lean tissue, and bone mineral, thus providing accurate estimates of bone mineral density, FM, and lean soft tissue/fat-free mass (FFM). The main limitations of DXA are that it is expensive, time-consuming, and exposes the subjects to radiation, which may hinder its use at a large scale. As body composition is more accurately assessed by fat percentage and FFM than BMI, it is relevant to consider which methods are most reliable for assessing body composition in transgender males.
We aim to investigate whether estimates of body composition by BIA in transgender males are significantly affected by the use of binary reference values. Furthermore, we aim to compare the body composition estimated by BIA to DXA scans.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans gender males | – | Radiation: Assessment of body compositionTrans gender males in hormonal therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Transgender males in hormonal therapy
Key inclusion criteria (3 listed)
- Trans gender males in hormonal therapy
- Age ≥ 18 years
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Inability to comprehend written consent form or provide informed consent
- BMI > 35
- Pregnancy
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 |
|---|---|---|
| Assessment of body compositionAssessment of body composition using BIA and DXA | Radiation | Trans gender males |
Primary outcome
Body fat percentage
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Signe Graungaard, MSc principal investigator
North Denmark Region
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 Transgenderism, run by Aalborg University Hospital at 1 site in Denmark.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Feb 2024. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body fat percentage (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.