Uncovering the effects of gender affirming hormone therapy on skeletal muscle and epigenetics : Protocol for a prospective matched cohort study in transgender individuals (the GAME study)

Journal article

Jones, Patrice R., Voisin, Sarah, Nolan, Brendan J., Landen, Shanie, Jacques, Macsue, Newell, Beau, Zwickl, Sav, Cook, Teddy, Wong, Alex, Ginger, Ariel, Palmer, Andrew, Garnham, Andrew, Alvarez-Romero, Javier, Mohandas, Namitha, Seale, Kirsten, Cheung, Ada and Eynon, Nir. (2022). Uncovering the effects of gender affirming hormone therapy on skeletal muscle and epigenetics : Protocol for a prospective matched cohort study in transgender individuals (the GAME study). BMJ Open. 12(5), p. Article e060869. https://doi.org/10.1136/bmjopen-2022-060869
AuthorsJones, Patrice R., Voisin, Sarah, Nolan, Brendan J., Landen, Shanie, Jacques, Macsue, Newell, Beau, Zwickl, Sav, Cook, Teddy, Wong, Alex, Ginger, Ariel, Palmer, Andrew, Garnham, Andrew, Alvarez-Romero, Javier, Mohandas, Namitha, Seale, Kirsten, Cheung, Ada and Eynon, Nir
Abstract

Introduction Gender affirming hormone therapy (GAHT) is increasingly used by transgender individuals and leads to shifts in sex hormone levels. Skeletal muscle is highly responsive to hormone activity, with limited data on the effects of GAHT on different human tissues. Here, we present the protocol for the GAME study (the effects of Gender Affirming hormone therapy on skeletal Muscle training and Epigenetics), which aims to uncover the effects of GAHT on skeletal muscle ‘omic’ profiles (methylomics, transcriptomics, proteomics, metabolomics) and markers of skeletal muscle health and fitness.

Methods and analysis This study is a prospective age-matched cohort study in transgender adults commencing GAHT (n=80) and age-matched individuals not commencing GAHT (n=80), conducted at Austin Health and Victoria University in Victoria, Australia. Assessments will take place prior to beginning GAHT and 6 and 12 months into therapies in adults commencing GAHT. Age-matched individuals will be assessed at the same time points. Assessments will be divided over three examination days, involving (1) aerobic fitness tests, (2) muscle strength assessments and (3) collection of blood and muscle samples, as well as body composition measurements. Standardised diets, fitness watches and questionnaires will be used to control for key confounders in analyses. Primary outcomes are changes in aerobic fitness and muscle strength, as well as changes in skeletal muscle DNA methylation and gene expression profiles. Secondary outcomes include changes in skeletal muscle characteristics, proteomics, body composition and blood markers. Linear mixed models will be used to assess changes in outcomes, while accounting for repeated measures within participants and adjusting for known confounders.

Ethics and dissemination The Austin Health Human Research Ethics Committee (HREC) and Victoria University HREC granted approval for this study (HREC/77146/Austin-2021). Findings from this project will be published in open-access, peer-reviewed journals and presented to scientific and public audiences.

Trial registration number ACTRN12621001415897; Pre-results.

KeywordsGender Affirming Hormone Therapy (GAHT); skeletal muscle; hormone activity; transgender adults; epigenetics; cohort study
Year2022
JournalBMJ Open
Journal citation12 (5), p. Article e060869
PublisherBMJ Publishing Group
ISSN2044-6055
Digital Object Identifier (DOI)https://doi.org/10.1136/bmjopen-2022-060869
PubMed ID35545400
Scopus EID2-s2.0-85129928054
PubMed Central IDPMC9096568
Open accessPublished as ‘gold’ (paid) open access
Page range1-8
FunderNational Health and Medical Research Council (NHMRC)
Publisher's version
License
File Access Level
Open
Output statusPublished
Publication dates
Online11 May 2022
Publication process dates
Accepted28 Apr 2022
Deposited14 Sep 2023
Grant ID1140644
11577321
1143333
2008956
2003939
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Evaluation of the MAIIA dipstick test to detect recombinant human erythropoietin in plasma
Ashenden, Michael, Sharpe, Ken, Garnham, Andrew and Gore, Christopher J.. (2012). Evaluation of the MAIIA dipstick test to detect recombinant human erythropoietin in plasma. Journal of Pharmaceutical and Biomedical Analysis. 67-68, pp. 123 - 128. https://doi.org/10.1016/j.jpba.2012.04.025
Activation of mTOR signalling in young and old human skeletal muscle in response to combined resistance exercise and whey protein ingestion
Farnfield, Michelle M., Breen, Leigh, Carey, Kate A., Garnham, Andrew and Cameron-Smith, David. (2012). Activation of mTOR signalling in young and old human skeletal muscle in response to combined resistance exercise and whey protein ingestion. Applied Physiology, Nutrition and Metabolism. 37(1), pp. 21 - 30. https://doi.org/10.1139/H11-132
Low muscle glycogen concentration does not suppress the anabolic response to resistance exercise
Camera, Donny, West, D, Burd, N, Phillips, S, Garnham, A, Hawley, John and Coffey, Vernon. (2012). Low muscle glycogen concentration does not suppress the anabolic response to resistance exercise. Journal of Applied Physiology. 113(2), pp. 206 - 214. https://doi.org/10.1152/japplphysiol.00395.2012
Nutrient provision increases signalling and protein synthesis in human skeletal muscle after repeated sprints
Coffey, Vernon, Moore, Daniel, Burd, N, Rerecich, T, Stellingwerff, T, Garnham, A, Phillips, S and Hawley, John. (2011). Nutrient provision increases signalling and protein synthesis in human skeletal muscle after repeated sprints. European Journal of Applied Physiology. 111(7), pp. 1473 - 1483. https://doi.org/10.1007/s00421-010-1768-0
Impact of resistance exercise training on interleukin-6 and JAK/STAT in young men
Trenerry, Marissa K., Della Gatta, Paul A., Larsen, Amy E., Garnham, Andrew P. and Cameron-Smith, David. (2011). Impact of resistance exercise training on interleukin-6 and JAK/STAT in young men. Muscle & Nerve. 43(3), pp. 385 - 392. https://doi.org/10.1002/mus.21875
Impact of resistance exercise training on interleukin-6 and JAK/STAT in young men
Trenerry, Melissa K., Della Gatta, Paul A., Larson, Amy E. and Garnham, Andrew P.. (2011). Impact of resistance exercise training on interleukin-6 and JAK/STAT in young men. Muscle & Nerve. 43(3), pp. 385 - 392. https://doi.org/10.1002/mus.21875
Vitamin D status and musculoskeletal health in adolescent male ballet dancers a pilot study
Ducher, Gaele, Kukuljan, Sonja, Hill, B., Garnham, Andrew P., Nowson, Carol A., Kimlin, M. G. and Cook, Jill. (2011). Vitamin D status and musculoskeletal health in adolescent male ballet dancers a pilot study. Journal of Dance Medicine and Science. 15(3), pp. 99 - 107.
Current markers of the Athlete Blood Passport do not flag microdose EPO doping
Ashenden, Michael, Gough, Clare E., Garnham, Andrew, Gore, Christopher J. and Sharpe, Ken. (2011). Current markers of the Athlete Blood Passport do not flag microdose EPO doping. European Journal of Applied Physiology. 111(9), pp. 2307 - 2314. https://doi.org/10.1007/s00421-011-1867-6
Exercise training increases adipose tissue GLUT4 expression in patients with type 2 diabetes
Hussey, Sophie E., McGee, S. L., Garnham, Andrew, Wentworth, John M., Jeukendrup, A. E. and Hargreaves, M.. (2011). Exercise training increases adipose tissue GLUT4 expression in patients with type 2 diabetes. Diabetes, Obesity and Metabolism. 13(10), pp. 959 - 962. https://doi.org/10.1111/j.1463-1326.2011.01426.x
Acute signalling responses to intense endurance training commenced with low or normal muscle glycogen : Experimental Physiology-Research Paper
Yeo, W, McGee, S, Carey, A, Paton, C, Garnham, A, Hargreaves, M and Hawley, John. (2010). Acute signalling responses to intense endurance training commenced with low or normal muscle glycogen : Experimental Physiology-Research Paper. Experimental Physiology. 95(2), pp. 351 - 358. https://doi.org/10.1113/expphysiol.2009.049353
Cytokine responses to carbohydrate ingestion during recovery from exercise-induced muscle injury
Ross, M, Halson, Shona, Suzuki, K, Garnham, A, Hawley, John, Cameron-Smith, David and Peake, J. (2010). Cytokine responses to carbohydrate ingestion during recovery from exercise-induced muscle injury. Journal of Interferon and Cytokine Research. 30(5), pp. 329 - 337. https://doi.org/10.1089/jir.2009.0079
Effect of consecutive repeated sprint and resistance exercise bouts on acute adaptive responses in human skeletal muscle
Coffey, Vernon Glenn, Jemiolo, Bozena, Edge, Johann, Garnham, Andrew P., Trappe, Scott W. and Hawley, John Alan. (2009). Effect of consecutive repeated sprint and resistance exercise bouts on acute adaptive responses in human skeletal muscle. American Journal of Physiology - Regulatory Integrative and Comparative Physiology. 297(5), pp. 1441 - 1451. https://doi.org/10.1152/ajpregu.00351.2009
Consecutive bouts of diverse contractile activity alter acute responses in human skeletal muscle
Coffey, Vernon Glenn, Pilegaard, Henriette, Garnham, Andrew P., O'Brien, Brendan J. and Hawley, John Alan. (2009). Consecutive bouts of diverse contractile activity alter acute responses in human skeletal muscle. Journal of Applied Physiology. 106(4), pp. 1187 - 1197. https://doi.org/10.1152/japplphysiol.91221.2008
Skeletal muscle adaptation and performance responses to once a day versus twice every second day endurance training regimens
Yeo, Wee Kian, Paton, Carl D., Garnham, Andrew P., Burke, Louise M., Carey, Andrew L. and Hawley, John Alan. (2008). Skeletal muscle adaptation and performance responses to once a day versus twice every second day endurance training regimens. Journal of Applied Physiology. 105(5), pp. 1462 - 1470. https://doi.org/10.1152/japplphysiol.90882.2008
Fat adaptation followed by carbohydrate restoration increases AMPK activity in skeletal muscle from trained humans
Yeo, Wee Kian, Lessard, Sarah J., Chen, Zhi-Ping, Garnham, Andrew P., Burke, Louise, Rivas, Donato A., Kemp, Bruce Ernest and Hawley, John Alan. (2008). Fat adaptation followed by carbohydrate restoration increases AMPK activity in skeletal muscle from trained humans. Journal of Applied Physiology. 105(5), pp. 1519 - 1526. https://doi.org/10.1152/japplphysiol.90540.2008