Please use this identifier to cite or link to this item: http://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.
Inder, W.
Jenkins, A.
Keech, A.
McLachlan, R.
Robledo, K.
Stuckey, B.
Yeap, B.
Citation: Diabetes, Obesity and Metabolism, 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.
RMID: 0030105686
DOI: 10.1111/dom.13601
Grant ID: http://purl.org/au-research/grants/nhmrc/1030123
Appears in Collections:Medicine publications

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