NCT05728853

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

13 days

First QC Date

February 6, 2023

Last Update Submit

January 31, 2024

Conditions

Transgenderism

Outcome Measures

Primary Outcomes (1)

  • Body fat percentage

    15 minutes

Study Arms (1)

Trans gender males

Trans gender males in hormonal therapy

Radiation: Assessment of body composition

Interventions

Assessment of body compositionRADIATION

Assessment of body composition using BIA and DXA

Trans gender males

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTrans gender males
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Transgender males in hormonal therapy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Officials

  • Signe Graungaard, MSc

    North Denmark Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Clinical Nutrition

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

April 20, 2023

Primary Completion

May 3, 2023

Study Completion

May 3, 2023

Last Updated

February 2, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)