Is Bioimpedance Analysis Accurate in Transgender Males?

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

Study Overview

• Status: Completed
• Conditions: Transgenderism
• Intervention / Treatment: Radiation: Assessment of body composition

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Transgender males in hormonal therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trans gender males; Trans gender males in hormonal therapy	Radiation: Assessment of body composition; Assessment of body composition using BIA and DXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body fat percentage	15 minutes

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Signe Graungaard, MSc, The North Denmark Region

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: N-20220054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No