Body Composition Assessment in Transgender Population.

NCT07481942 | Completed FDA Drug

• 1 other identifier: CEIm:109/16
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Gender-affirming hormone therapy (GAHT) is a fundamental component of medical transition in transgender men, promoting body composition changes that align physical characteristics with gender identity and alleviate gender dysphoria. In adults, GAHT typically involves testosterone administration, whereas adolescents may receive gonadotropin-releasing hormone agonists to suppress puberty before initiating testosterone. Despite its general safety when appropriately monitored, findings on GAHT-related changes in body composition and potential cardiovascular implications are inconsistent. Accurate assessment of skeletal muscle mass and fat redistribution is clinically relevant, as conventional anthropometric measures may fail to capture these changes. This study evaluates body composition changes after one year of testosterone therapy in transgender men using bioelectrical impedance vector analysis (BIVA), and explores the utility of muscle ultrasound as an accessible tool for monitoring skeletal muscle and potential differences among testosterone formulations.

Conditions

Transgender

Keywords

visceral fat; bioimpedance; cardiovascular risk; body composition; muscular ultrasound

Outcome Measures

Primary Outcomes (3)

• Examine the increase in skeletal muscle mass after one year of testosterone treatment on body composition in transgender men using bioelectrical impedance vector analysis.

  To assess if there is a significant skeletal muscle mass gain after one year of testosterone treatment, skeletal muscle mass will be predicted using predictive equations with both resistance and resistence measured using bioelectrical impedance vector analysis. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval.

  5 years

• Explore the utility of muscle ultrasound as a feasible tool for monitoring skeletal muscle during masculinization hormonal treatment

  Muscle ultrasound will be performed on a subsample using a DP-50 Expert Mobile Ultrasound System (Mindray®) equipped with a 5-10 MHz linear transducer. Examinations will be conducted at baseline, 6 months, and 12 months. Participants will be positioned supine with legs extended and instructed to refrain from exercise for at least 30 minutes before testing. Images will be obtained at the midpoint between the anterior superior iliac spine and the patella. Bilateral quadriceps muscle thickness (right and left; RQU and LQU) will be measured as the distance between the superficial and deep aponeuroses. Thickness of the rectus femoris and vastus intermedius will be recorded along the transverse axis. To check if RQU and LQU can predict skeletal muscle mass gain, regression models will be performed (square R coefficient \> 0,6). Acceptable sensitivity and specificity from RQU and LQU as predictors of skeletal muscle mass will be considered if their values are above 70%.

  5 years

• Assess significant changes in skeletal muscle mass gain according to type of testosterone formulation used

  Skeletal muscle mass gain will be assessed by calculating the difference between final and baseline values obtained from body composition evaluations. Significant differences between types of testosterone formulations will be considered when notable differences in mean values between groups are observed, as determined by a p-value \< 0.05 using multiple pairwise comparisons followed by post hoc analysis, with a 95% confidence interval.

  5 years

Secondary Outcomes (8)

• Evaluate significant changes in visceral fat after one year of testosterone treatment

  4 years

• Quantify skeletal muscle mass gain through one year of testosterone treatment

  4 years

• Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after one year of testosterone treatment.

  4 years

• Evaluate if there is a significant reduction after one year of testosterone treatment in HOMA-IR levels.

  4 years

• Analyze the changes in ApoB/ApoA1 ratio after one year of gender-affirming hormone therapy.

  4 years

Study Arms (2)

Transgender men using transdermic testosterone gel

Transgender men who initiate 50 mg/day of transdermic testosterone gel as gender affirming hormone therapy (according to european guidelines).

Drug: gender affirming hormone therapy

Transgender men using intramuscularly administered testosterone

Transgender men who initiate 1,000 mg of intramuscularly administered testosterone undecanoate every 6 weeks, and then every 12 weeks (and, in case of testosterone undecanoate stock-out, with 200-250 mg of intramuscularly administered testosterone cypionate) as gender affirming hormone therapy (according to european guidelines).

Drug: gender affirming hormone therapy

Interventions

gender affirming hormone therapy DRUG

Participants will be treated with testosterone according to the World Professional Association for Transgender Health (WPATH) guidelines. Pharmaceutical presentation of testosterone will be consensually chosen by participants together with their endocrinologists. This include 1,000 mg of intramuscularly administered testosterone undecanoate every 6 weeks after initiation of GAHT and then every 12 weeks (and, in case of testosterone undecanoate stock-out, with 200-250 mg of intramuscularly administered testosterone cypionate), or 50 mg/day of transdermic testosterone gel (Tgel), according to European guidelines. For adolescents, GAHT may be combined with puberty suppression using gonadotropin-releasing hormone agonist (GnRHa), when indicated, and these agents will be continued in adults if menses persisted despite testosterone escalation.

Transgender men using intramuscularly administered testosterone; Transgender men using transdermic testosterone gel

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Participants included individuals who identified as men, as well as non-binary individuals seeking or identifying with a masculine physical appearance.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from the Gender Identity Unit of the Department of Endocrinology and Nutrition at University Hospital Doctor Peset (Valencia, Spain). All individuals underwent psychological evaluation by an experienced sexologist, who confirmed gender dysphoria according to DSM-V criteria, and prior to inclusion had been approved for gender-affirming medical intervention.

You may qualify if:

• Transgender men with confirmed gender dysphoria according to DSM-V criteria by an experienced sexologist.
• Testosterone-naïve status
• ≥14 years
• Absence of prior or planned mastectomy or genital surgery during the study period

You may not qualify if:

• Diagnosed eating disorders, severe illness, neuromuscular or malignant disease, cardiovascular disease, and/or diabetes mellitus
• Conditions contraindicating bioelectrical impedance analysis (pregnancy, lactation, or pacemaker)

Sponsors & Collaborators

• Celia Bañuls: lead

Study Sites (1)

FISABIO

Valencia, Valencia, 46020, Spain

Location

Related Publications (16)

• Aranda G, Mora M, Hanzu FA, Vera J, Ortega E, Halperin I. Effects of sex steroids on cardiovascular risk profile in transgender men under gender affirming hormone therapy. Endocrinol Diabetes Nutr (Engl Ed). 2019 Jun-Jul;66(6):385-392. doi: 10.1016/j.endinu.2018.11.004. Epub 2019 Jan 28. English, Spanish.

  PMID: 30704917 BACKGROUND

• Waters J, Linsenmeyer W. The impact of gender-affirming hormone therapy on nutrition-relevant biochemical measures. Front Nutr. 2024 Apr 5;11:1339311. doi: 10.3389/fnut.2024.1339311. eCollection 2024.

  PMID: 38646103 BACKGROUND

• Lundberg TR, Tryfonos A, Eriksson LMJ, Rundqvist H, Rullman E, Holmberg M, Maqdasy S, Linge J, Leinhard OD, Arver S, Andersson DP, Wiik A, Gustafsson T. Longitudinal changes in regional fat and muscle composition and cardiometabolic biomarkers over 5 years of hormone therapy in transgender individuals. J Intern Med. 2025 Feb;297(2):156-172. doi: 10.1111/joim.20039. Epub 2024 Nov 27.

  PMID: 39604308 BACKGROUND

• Leemaqz SY, Kyinn M, Banks K, Sarkodie E, Goldstein D, Irwig MS. Lipid profiles and hypertriglyceridemia among transgender and gender diverse adults on gender-affirming hormone therapy. J Clin Lipidol. 2023 Jan-Feb;17(1):103-111. doi: 10.1016/j.jacl.2022.11.010. Epub 2022 Nov 22.

  PMID: 36473821 BACKGROUND

• Auer MK, Ebert T, Pietzner M, Defreyne J, Fuss J, Stalla GK, T'Sjoen G. Effects of Sex Hormone Treatment on the Metabolic Syndrome in Transgender Individuals: Focus on Metabolic Cytokines. J Clin Endocrinol Metab. 2018 Feb 1;103(2):790-802. doi: 10.1210/jc.2017-01559.

  PMID: 29216353 BACKGROUND

• Gava G, Mancini I, Cerpolini S, Baldassarre M, Seracchioli R, Meriggiola MC. Testosterone undecanoate and testosterone enanthate injections are both effective and safe in transmen over 5 years of administration. Clin Endocrinol (Oxf). 2018 Dec;89(6):878-886. doi: 10.1111/cen.13821. Epub 2018 Aug 12.

  PMID: 30025172 BACKGROUND

• Fu H, Wang L, Zhang W, Lu J, Yang M. Diagnostic test accuracy of ultrasound for sarcopenia diagnosis: A systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2023 Feb;14(1):57-70. doi: 10.1002/jcsm.13149. Epub 2022 Dec 13.

  PMID: 36513380 BACKGROUND

• Marin Baselga R, Teigell-Munoz FJ, Porcel JM, Ramos Lazaro J, Garcia Rubio S. Ultrasound for body composition assessment: a narrative review. Intern Emerg Med. 2025 Jan;20(1):23-34. doi: 10.1007/s11739-024-03756-8. Epub 2024 Sep 6.

  PMID: 39240412 BACKGROUND

• Spanos C, Bretherton I, Zajac JD, Cheung AS. Effects of gender-affirming hormone therapy on insulin resistance and body composition in transgender individuals: A systematic review. World J Diabetes. 2020 Mar 15;11(3):66-77. doi: 10.4239/wjd.v11.i3.66.

  PMID: 32180895 BACKGROUND

• Ford K, Huggins E, Sheean P. Characterising body composition and bone health in transgender individuals receiving gender-affirming hormone therapy. J Hum Nutr Diet. 2022 Dec;35(6):1105-1114. doi: 10.1111/jhn.13027. Epub 2022 May 22.

  PMID: 35509260 BACKGROUND

• Klaver M, Dekker MJHJ, de Mutsert R, Twisk JWR, den Heijer M. Cross-sex hormone therapy in transgender persons affects total body weight, body fat and lean body mass: a meta-analysis. Andrologia. 2017 Jun;49(5). doi: 10.1111/and.12660. Epub 2016 Aug 29.

  PMID: 27572683 BACKGROUND

• Ceolin C, Scala A, Scagnet B, Citron A, Vilona F, De Rui M, Miscioscia M, Camozzi V, Ferlin A, Sergi G, Garolla A; GIIG group. Body composition and perceived stress levels in transgender individuals after one year of gender affirming hormone therapy. Front Endocrinol (Lausanne). 2024 Nov 28;15:1496160. doi: 10.3389/fendo.2024.1496160. eCollection 2024.

  PMID: 39669495 BACKGROUND

• Miroshnychenko A, Ibrahim S, Roldan Y, Kulatunga-Moruzi C, Montante S, Couban R, Guyatt G, Brignardello-Petersen R. Gender affirming hormone therapy for individuals with gender dysphoria aged <26 years: a systematic review and meta-analysis. Arch Dis Child. 2025 May 16;110(6):437-445. doi: 10.1136/archdischild-2024-327921.

  PMID: 39855725 BACKGROUND

• Tornese G, Di Mase R, Munarin J, Ciancia S, Santamaria F, Fava D, Candela E, Capalbo D, Ungaro C, Improda N, Diana P, Matarazzo P, Guazzarotti L, Toschetti T, Sambati V, Tamaro G, Bresciani G, Licenziati MR, Street ME, Aversa T, Delvecchio M, Faienza MF, Iughetti L, Calcaterra V, de Sanctis L, Salerno M, Franceschi R. Use of gonadotropin-releasing hormone agonists in transgender and gender diverse youth: a systematic review. Front Endocrinol (Lausanne). 2025 May 14;16:1555186. doi: 10.3389/fendo.2025.1555186. eCollection 2025.

  PMID: 40438403 BACKGROUND

• Coleman E, Radix AE, Bouman WP, Brown GR, de Vries ALC, Deutsch MB, Ettner R, Fraser L, Goodman M, Green J, Hancock AB, Johnson TW, Karasic DH, Knudson GA, Leibowitz SF, Meyer-Bahlburg HFL, Monstrey SJ, Motmans J, Nahata L, Nieder TO, Reisner SL, Richards C, Schechter LS, Tangpricha V, Tishelman AC, Van Trotsenburg MAA, Winter S, Ducheny K, Adams NJ, Adrian TM, Allen LR, Azul D, Bagga H, Basar K, Bathory DS, Belinky JJ, Berg DR, Berli JU, Bluebond-Langner RO, Bouman MB, Bowers ML, Brassard PJ, Byrne J, Capitan L, Cargill CJ, Carswell JM, Chang SC, Chelvakumar G, Corneil T, Dalke KB, De Cuypere G, de Vries E, Den Heijer M, Devor AH, Dhejne C, D'Marco A, Edmiston EK, Edwards-Leeper L, Ehrbar R, Ehrensaft D, Eisfeld J, Elaut E, Erickson-Schroth L, Feldman JL, Fisher AD, Garcia MM, Gijs L, Green SE, Hall BP, Hardy TLD, Irwig MS, Jacobs LA, Janssen AC, Johnson K, Klink DT, Kreukels BPC, Kuper LE, Kvach EJ, Malouf MA, Massey R, Mazur T, McLachlan C, Morrison SD, Mosser SW, Neira PM, Nygren U, Oates JM, Obedin-Maliver J, Pagkalos G, Patton J, Phanuphak N, Rachlin K, Reed T, Rider GN, Ristori J, Robbins-Cherry S, Roberts SA, Rodriguez-Wallberg KA, Rosenthal SM, Sabir K, Safer JD, Scheim AI, Seal LJ, Sehoole TJ, Spencer K, St Amand C, Steensma TD, Strang JF, Taylor GB, Tilleman K, T'Sjoen GG, Vala LN, Van Mello NM, Veale JF, Vencill JA, Vincent B, Wesp LM, West MA, Arcelus J. Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-S259. doi: 10.1080/26895269.2022.2100644. eCollection 2022.

  PMID: 36238954 BACKGROUND

• Gois I, Rodrigues FB, Pereira M, Dias-da-Silva MR, Gomes SM. Body mass index and body composition changes in transgender people undergoing gender-affirming hormone therapy: a systematic review and meta-analysis. Rev Endocr Metab Disord. 2025 Dec;26(6):937-953. doi: 10.1007/s11154-025-09985-2. Epub 2025 Jun 26.

  PMID: 40569560 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: January 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: October 31, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)