Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05728853 |
| Other study ID # |
N-20220054 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2023 |
| Est. completion date |
May 3, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Aalborg University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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
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.
