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https://hdl.handle.net/2440/118552
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Type: | Journal article |
Title: | Testosterone therapy to prevent type 2 diabetes mellitus in at-risk men (T4DM): design and implementation of a double-blind randomized controlled trial |
Author: | Wittert, G. Atlantis, E. Allan, C. Bracken, K. Conway, A. Daniel, M. Gebski, V. Grossmann, M. Hague, W. Handelsman, D.J. Inder, W. Jenkins, A. Keech, A. McLachlan, R. Robledo, K. Stuckey, B. Yeap, B.B. |
Citation: | Diabetes, Obesity and Metabolism: a journal of pharmacology and therapeutics, 2019; 21(4):772-780 |
Publisher: | Wiley Online Library |
Issue Date: | 2019 |
ISSN: | 1462-8902 1463-1326 |
Statement of Responsibility: | Gary Wittert, Evan Atlantis, Carolyn Allan, Karen Bracken, Ann Conway, Mark Daniel ... et al. |
Abstract: | BACKGROUND:Low circulating testosterone is associated with an increased risk of developing type 2 diabetes (T2DM) in overweight men with impaired glucose tolerance (IGT). AIMS:To determine in a multi-centre, double-blinded placebo-controlled randomized trial whether testosterone treatment combined with lifestyle intervention (Weight Watchers) relative to lifestyle intervention alone reduces T2DM incidence and improves glucose tolerance at 2 years. STUDY POPULATION:Overweight or obese men aged 50-74 years with a serum testosterone of ≤14 nmol/L and IGT or newly diagnosed T2DM established by an oral glucose tolerance test (OGTT). SETTING, DRUG AND PROTOCOL:Six Australian capital city-based tertiary care centres. Participants were randomized 1:1 and injected with testosterone undecanoate (1000 mg/4 mL) or vehicle (4 mL castor oil), at baseline, 6 weeks and 3-monthly thereafter. PRIMARY ENDPOINTS: (a) Proportion of participants with 2-hour OGTT ≥11.1 mmol/L at 2 years, and (b) a difference at 2 years ≥0.6 mmol/L in the mean 2-hour OGTT glucose between treatments. SECONDARY ENDPOINTS:Fasting insulin, HbA1c, body composition, maximal handgrip strength; sexual function and lower urinary tract symptoms; serum sex steroids and sex hormone binding globulin; mood and psychosocial function; adherence to lifestyle intervention; and healthcare utilization and costs. SAFETY:Overseen by an Independent Data Safety Monitoring Committee. Haematocrit, lipids and prostate-specific antigen (PSA) are assessed 6-monthly and information relating to haematological, urological and cardiovascular adverse events from each clinic visit. SUB-STUDIES: (a) Changes in bone density and micro-architecture, (b) motivation and behaviour, (c) telomere length, (d) extended treatment up to 4 years, and (e) hypothalamo-pituitary testicular axis recovery at treatment end. |
Keywords: | body composition cardiovascular motivation obesity prevention testosterone type 2 diabetes mellitus |
Rights: | © 2018 John Wiley & Sons Ltd. |
DOI: | 10.1111/dom.13601 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1030123 |
Published version: | http://dx.doi.org/10.1111/dom.13601 |
Appears in Collections: | Aurora harvest 4 Medicine publications |
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