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Title: | Testosterone therapy reduces insulin resistance in men with adult-onset testosterone deficiency and metabolic syndrome. Results from the Moscow Study, a randomized controlled trial with an open-label phase |
Authors: | Tishova, Y Kalinchenko, S Mskhalaya, G Hackett, G Livingston, M König, C Strange, R Zitzmann, M Mann, A Maarouf, A Ramachandran, S |
Keywords: | adult-onset hypogonadism;insulin resistance;metabolic syndrome;testosterone therapy;waist circumference |
Issue Date: | 3-Mar-2024 |
Publisher: | Wiley |
Citation: | Tishova, Y. et al. (2024) 'Testosterone therapy reduces insulin resistance in men with adult-onset testosterone deficiency and metabolic syndrome. Results from the Moscow Study, a randomized controlled trial with an open-label phase', Diabetes, Obesity and Metabolism, 26 (6), pp. 2147 - 2157. doi: 10.1111/dom.15520. |
Abstract: | Aims: To describe changes in homeostasis model assessment of insulin resistance index (HOMA-IR) following testosterone therapy in men with hypogonadism and metabolic syndrome (MetS). Materials and Methods: A randomized, placebo-controlled, double-blind randomized controlled trial (RCT) comprising 184 men with MetS and hypogonadism (testosterone undecanoate [TU]: 113 men, placebo: 71 men) was conducted. This was followed by an open-label phase in which all men were given TU. We focused on men who were not receiving antiglycaemic agents (TU: 81 men; placebo: 54 men) as these could affect HOMA-IR. Inter-group comparison of HOMA-IR was restricted to the RCT (30 weeks), whilst intra-group comparison was carried out on men provided TU during the RCT and open-label phases (study cohort) and men given placebo during the RCT and then switched to TU during the open-label phase (confirmatory cohort). Regression analysis was performed to identify factors associated with change in HOMA-IR (∆HOMA-IR). Results: The median HOMA-IR was significantly reduced at almost every time point (after 18 weeks) compared to baseline in men receiving TU in both the study and confirmatory cohorts. There was a significant decrease in median values of fasting glucose (30 weeks: −2.1%; 138 weeks: −4.9%) and insulin (30 weeks: −10.5%; 138 weeks: −35.5%) after TU treatment. Placebo was not associated with significant ∆HOMA-IR. The only consistent predictor of HOMA-IR decrease following TU treatment was baseline HOMA-IR (r2 ≥ 0.64). Conclusions: Baseline HOMA-IR predicted ΔHOMA-IR, with a greater percentage change in insulin than in fasting glucose. In men with MetS/type 2 diabetes (T2DM) not on antiglycaemic therapy, improvements in HOMA-IR may be greater than suggested by change in fasting glucose. Our results suggest that hypogonadism screening be included in the management of men with MetS/T2DM. |
Description: | Data Availability Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request. |
URI: | https://bura.brunel.ac.uk/handle/2438/30096 |
DOI: | https://doi.org/10.1111/dom.15520 |
ISSN: | 1462-8902 |
Other Identifiers: | ORCiD: Carola König https://orcid.org/0000-0002-9289-3154 |
Appears in Collections: | Dept of Mechanical and Aerospace Engineering Research Papers |
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