Effect of Testosterone Treatment on Constitutional and Sexual Symptoms in Men With Type 2 Diabetes in a Randomized, Placebo-Controlled Clinical Trial
Abstract
OBJECTIVE: The objective of the study was to assess the effect of T treatment on constitutional and sexual symptoms in men with type 2 diabetes (T2D). DESIGN: This was a randomized double-blind, parallel, placebo-controlled trial. SETTING: The study was conducted at a tertiary referral center. PATIENTS: Men aged 35-70 years with T2D, a hemoglobin A1c less than 8.5%, and a total T level less than 12.0 nmol/L (346 ng/dL) with mild to moderate aging male symptoms and erectile dysfunction. INTERVENTION: Eighty-eight participants were randomly assigned to 40 weeks of im T undecanoate (n = 45) or matching placebo (n = 43). MAIN OUTCOME MEASURES: Constitutional symptoms using the aging male symptoms (AMS) score, sexual desire (question 17 AMS score), and erectile function (International Index of Erectile Function-5). RESULTS: T treatment did not substantially improve aging male symptoms [mean adjusted difference (MAD) in change over 40 weeks across the T and placebo groups in AMS total score, -0.9 (95% confidence interval [CI] -4.1, 2.2), P = .67] or sexual desire [MAD in question 17 AMS, -0.3 (95% CI -0.8, 0.2), P = .17]. Although compared with placebo, erectile function in men assigned to T was reduced [MAD in International Index of Erectile Function abridged version 5, -2.0 (95% CI -3.4, -0.6), P < .02], there was no significant difference between baseline and 40-week International Index of Erectile Function abridged version 5 scores if both groups were analyzed separately. At baseline, symptoms were worse in men with depression and microvascular complications but did not correlate with T levels. CONCLUSIONS: In this trial, T treatment did not substantially improve constitutional or sexual symptoms in obese, aging men with T2D with mild to moderate symptoms and modest reduction in T levels typical for the vast majority of such men.
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In an RCT in older men with long-standing diabetes (mean duration 8-9 years) and a high comorbid burden, testosterone treatment did not improve androgen deficiency-like symptoms or sexual function.
“Interestingly, in an RCT using the same questionnaires as Ng Tang Fui's study, 91,101 but in a cohort of older men with long-standing diabetes (mean duration 8-9 years) and a high comorbid burden, testosterone treatment did not improve androgen deficiency-like symptoms or sexual function.105”
From Hypogonadism and male obesity: Focus on unresolved questions (2018) · cites this paper as [105]
Cites
R: A Language and Environment for Statistical Computing
R Core Team (2000) · doi:10.32614/r.manuals · Cited by 355,706 · see citing works
Charlson, M. E., Pompei, P., Ales, K. L., & MacKenzie, C. R. (1987) · Journal of Chronic Diseases · doi:10.1016/0021-9681(87)90171-8 · Cited by 49,742 · see citing works
Rosen, R., Cappelleri, J. C., Smith, M., Lipsky, J., & Peña, B. (1999) · International Journal of Impotence Research · doi:10.1038/sj.ijir.3900472 · Cited by 3,069 · see citing works
Turner, R. C., Millns, H., Neil, H. A. W., Stratton, I. M., Manley, S. E., Matthews, D. R., & Holman, R. R. (1998) · BMJ · doi:10.1136/bmj.316.7134.823 · Cited by 2,014 · see citing works
Bhasin, S., Cunningham, G. R., Hayes, F. J., Matsumoto, A. M., Snyder, P. J., Swerdloff, R. S., & Montori, V. M. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2009-2354 · Cited by 1,954 · see citing works
Identification of late-onset hypogonadism in middle-aged and elderly men
Wu, F. C. W., Tajar, A., Beynon, J. M., Pye, S. R., Silman, A. J., Finn, J. D., O'Neill, T. W., Bartfai, G., Casanueva, F. F., Forti, G., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0911101 · Cited by 1,544 · see citing works
Adverse Events Associated with Testosterone Administration
Basaria, S., Coviello, A. D., Travison, T. G., Storer, T. W., Farwell, W. R., Jette, A. M., Eder, R., Tennstedt, S., Ulloor, J., Zhang, A., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1000485 · Cited by 1,494 · see citing works
Ding, E. L., Song, Y., Malik, V. S., & Liu, S. (2006) · JAMA · doi:10.1001/jama.295.11.1288 · Cited by 1,354 · see citing works
Bhasin, S., Cunningham, G. R., Hayes, F. J., Matsumoto, A. M., Snyder, P. J., Swerdloff, R. S., & Montori, V. M. (2006) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2005-2847 · Cited by 965 · see citing works
Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men
Finkle, W. D., Greenland, S., Ridgeway, G. K., Adams, J. L., Frasco, M. A., Cook, M. B., Fraumeni, J. F., & Hoover, R. N. (2014) · PLoS ONE · doi:10.1371/journal.pone.0085805 · Cited by 735 · see citing works
Adverse Effects of Testosterone Therapy in Adult Men: A Systematic Review and Meta-Analysis
Fernández-Balsells, M. M., Murad, M. H., Lane, M., Lampropulos, J. F., Albuquerque, F., Mullan, R. J., Agrwal, N., Elamin, M. B., Gallegos-Orozco, J. F., Wang, A. T., et al. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2009-2575 · Cited by 713 · see citing works
Frequent Occurrence of Hypogonadotropic Hypogonadism in Type 2 Diabetes
Dhindsa, S., Prabhakar, S., Sethi, M., Bandyopadhyay, A., Chaudhuri, A., & Dandona, P. (2004) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2004-0804 · Cited by 631 · see citing works
Jones, T. H., Arver, S., Behre, H. M., Buvat, J., Meuleman, E., Moncada, I., Morales, A. M., Volterrani, M., Yellowlees, A., Howell, J. D., et al. (2011) · Diabetes Care · doi:10.2337/dc10-1233 · Cited by 548 · see citing works
Clinical and Biochemical Assessment of Hypogonadism in Men With Type 2 Diabetes
Kapoor, D., Aldred, H., Clark, S., Channer, K. S., & Jones, T. H. (2007) · Diabetes Care · doi:10.2337/dc06-1426 · Cited by 493 · see citing works
Low testosterone levels are common and associated with insulin resistance in men with diabetes
Grossmann, M., Thomas, M. C., Panagiotopoulos, S., Sharpe, K., MacIsaac, R. J., Clarke, S., Zajac, J. D., & Jerums, G. (2008) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2007-2177 · Cited by 468 · see citing works
Self-citationType 2 diabetes mellitus and testosterone: a meta-analysis study: Type 2 diabetes and testosterone
Corona, G., Monami, M., Rastrelli, G., Aversa, A., Sforza, A., Lenzi, A., Forti, G., Mannucci, E., & Maggi, M. (2011) · International Journal of Andrology · doi:10.1111/j.1365-2605.2010.01117.x · Cited by 370 · see citing works
Low Testosterone in Men with Type 2 Diabetes: Significance and Treatment
Grossmann, M. (2011) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2011-0118 · Cited by 350 · see citing works
Self-citationSikaris, K., McLachlan, R. I., Kazlauskas, R., de Kretser, D., Holden, C. A., & Handelsman, D. J. (2005) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2005-0962 · Cited by 259 · see citing works
Handelsman, D. J. (2013) · Medical Journal of Australia · doi:10.5694/mja13.10111 · Cited by 253 · see citing works
Harwood, D. T., & Handelsman, D. J. (2009) · Clinica Chimica Acta · doi:10.1016/j.cca.2009.09.003 · Cited by 243 · see citing works
Hackett, G., Cole, N., Bhartia, M., Kennedy, D., Raju, J., & Wilkinson, P. (2013) · The Journal of Sexual Medicine · doi:10.1111/jsm.12146 · Cited by 182 · see citing works
ORIGINAL ARTICLE: Accuracy of calculated free testosterone formulae in men
Ly, L. P., Sartorius, G., Hull, L., Leung, A., Swerdloff, R. S., Wang, C., & Handelsman, D. J. (2010) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2010.03804.x · Cited by 172 · see citing works
Hackett, G., Cole, N., Bhartia, M., Kennedy, D., Raju, J., Wilkinson, P., & the BLAST Study Group (2014) · The Journal of Sexual Medicine · doi:10.1111/jsm.12404 · Cited by 168 · see citing works
Gianatti, E., Dupuis, P., Hoermann, R., Strauss, B. J., Wentworth, J. M., Zajac, J. D., & Grossmann, M. (2014) · Diabetes Care · doi:10.2337/dc13-2845 · Cited by 166 · see citing works
Self-citationRisks and benefits of testosterone therapy in older men
Spitzer, M., Huang, G., Basaria, S., Travison, T. G., & Bhasin, S. (2013) · Nature Reviews Endocrinology · doi:10.1038/nrendo.2013.73 · Cited by 154 · see citing works
Bhasin, S., Cunningham, G. R., Hayes, F. J., Matsumoto, A. M., Snyder, P. J., Swerdloff, R. S., & Montori, V. M. (2010) · The Journal of Clinical Endocrinology & Metabolism · Cited by 149 · see citing works
Giltay, E. J., Tishova, Y. A., Mskhalaya, G. J., Gooren, L. J. G., Saad, F., & Kalinchenko, S. Y. (2010) · The Journal of Sexual Medicine · doi:10.1111/j.1743-6109.2010.01859.x · Cited by 140 · see citing works
Aging Males' Symptoms scale: a standardized instrument for the practice.
Heinemann, L. A. J. (2005) · PubMed · Cited by 56 · see citing works
Biswas, M., Hampton, D., Newcombe, R. G., & Rees, A. (2011) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2011.04196.x · Cited by 46 · see citing works
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Self-citationGrossmann, M., Hoermann, R., Wittert, G., & Yeap, B. B. (2015) · Clinical Endocrinology · doi:10.1111/cen.12664 · Cited by 139 · see citing works
Self-citationGiagulli, V. A., Carbone, M. D., Ramunni, M. I., Licchelli, B., De Pergola, G., Sabbà, C., Guastamacchia, E., & Triggiani, V. (2015) · Andrology · doi:10.1111/andr.12099 · Cited by 109 · see citing works
Effects of liraglutide on obesity-associated functional hypogonadism in men
Jensterle, M., Podbregar, A., Goricar, K., Gregoric, N., & Janez, A. (2019) · Endocrine Connections · doi:10.1530/ec-18-0514 · Cited by 101 · see citing works
Treatment of Men for “Low Testosterone”: A Systematic Review
Huo, S., Scialli, A. R., McGarvey, S., Hill, E., Tügertimur, B., Hogenmiller, A., Hirsch, A. I., & Fugh-Berman, A. (2016) · PLOS ONE · doi:10.1371/journal.pone.0162480 · Cited by 97 · see citing works
Ng Tang Fui, M., Hoermann, R., Prendergast, L. A., Zajac, J. D., & Grossmann, M. (2017) · International Journal of Obesity · doi:10.1038/ijo.2016.242 · Cited by 40 · see citing works
Self-citationMelehan, K. L., Hoyos, C. M., Yee, B. J., Wong, K. K., Buchanan, P. R., Grunstein, R. R., & Liu, P. Y. (2016) · Andrology · doi:10.1111/andr.12132 · Cited by 26 · see citing works
- Authors
- Gianatti, E. J., Dupuis, P., Hoermann, R., Zajac, J. D., & Grossmann, M.
- Affiliations
- The University of Melbourne (AU)
- Corresponding author
- Grossmann, Mathis
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2014-10
- Volume
- 99
- Issue
- 10
- Pages
- 3821-3828
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2115164543
- Cited by
- 67
- References
- 29
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 5 · 2023: 5 · 2022: 5 · 2021: 3 · 2020: 4 · 2019: 7 · 2018: 5 · 2017: 10 · 2016: 7 · 2015: 9 · 2014: 4
- FWCI
- 8.04
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Minerva Access (University of Melbourne) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- testosterone replacement therapy, type 2 diabetes, aging male symptoms, erectile dysfunction, sexual desire, constitutional symptoms, male hypogonadism, depression, microvascular complications, obesity
- MeSH terms
- Adult, Aged, Aging, Androgens, Depression, Diabetes Mellitus, Type 2, Double-Blind Method, Humans, Erectile Dysfunction, Libido, Male, Middle Aged, Obesity, Placebos, Testosterone, Treatment Outcome, Hormone Replacement Therapy
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