Is Bioimpedance Analysis Accurate in Transgender Males?

NCT ID: NCT05728853

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2023-05-03

Brief 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

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Trans gender males

Trans gender males in hormonal therapy

Assessment of body composition

Intervention Type: RADIATION

Assessment of body composition using BIA and DXA

Interventions

Assessment of body composition

Assessment of body composition using BIA and DXA

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Trans gender males in hormonal therapy
• Age ≥ 18 years
• Ability to provide informed consent

Exclusion Criteria

• Inability to comprehend written consent form or provide informed consent
• BMI > 35
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Signe Graungaard

MSc Clinical Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Signe Graungaard, MSc

Role: PRINCIPAL_INVESTIGATOR

North Denmark Region

Locations

Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

N-20220054

Identifier Type: -

Identifier Source: org_study_id