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

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. © 2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Авторы
Tishova Y. , Kalinchenko S. , Mskhalaya G. , Hackett G. , Livingston M. , König C. , Strange R. , Zitzmann M. , Mann A. , Maarouf A. , Ramachandran S.
Издательство
John Wiley and Sons Inc
Номер выпуска
6
Язык
Английский
Страницы
2147-2157
Статус
Опубликовано
Том
26
Год
2024
Организации
  • 1 Department of Endocrinology, Medical Clinic K-medicine, Moscow, Russian Federation
  • 2 Department of Endocrinology, People's Friendship University of Russia, Moscow, Russian Federation
  • 3 Department of Preventive Medicine, European Medical Center, Moscow, Russian Federation
  • 4 School of Health and Life Sciences, Aston University, Birmingham, United Kingdom
  • 5 Department of Clinical Biochemistry, Black Country Pathology Services, Walsall Manor Hospital, United Kingdom
  • 6 School of Medicine and Clinical Practice, Faculty of Science and Engineering, The University of Wolverhampton, Wolverhampton, United Kingdom
  • 7 Department of Mechanical and Aerospace Engineering, Brunel University, London, United Kingdom
  • 8 School of Pharmacy and Bioengineering, Keele University, Staffordshire, United Kingdom
  • 9 Department of Clinical and Surgical Andrology, Centre of Reproductive Medicine and Andrology, Munster University Hospital, Munster, Germany
  • 10 Department of Clinical Biochemistry, University Hospitals Birmingham NHS Foundation Trust, West Midlands, United Kingdom
  • 11 Department of Clinical Biochemistry, University Hospitals of North Midlands NHS Foundation Trust, Staffordshire, United Kingdom
Ключевые слова
adult-onset hypogonadism; insulin resistance; metabolic syndrome; testosterone therapy; waist circumference
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