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Title: Testosterone therapy to prevent type 2 diabetes mellitus in at-risk men (T4DM): Design and implementation of a double-blind randomised controlled trial.
Austin Authors: Wittert, Gary;Atlantis, Evan;Allan, Carolyn;Bracken, Karen;Conway, Ann;Daniel, Mark;Gebski, Val;Grossmann, Mathis ;Hague, Wendy;Handelsman, David;Inder, Warrick;Jenkins, Alicia;Keech, Anthony;McLachlan, Rob;Robledo, Kristy;Stuckey, Bronwyn;Yeap, Bu B
Affiliation: University of Canberra, Australian Capital Territory, Australia
Princess Alexandra Hospital and University of Queensland, Queensland, Australia
Anzac Research Institute and Concord Hospital, Sydney, New South Wales, Australia
School of Medicine, University of Adelaide, Adelaide, South Australia, Australia
School of Nursing and Midwifery, Western Sydney University, Australia
Medical School, University of Western Australia, and Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Perth, Western Australia, Australia
Keogh Institute of Medical Research and University of Western Australia, Western Australia, Australia
NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia
Hudson Institute of Medical Research, Victoria, Australia
Issue Date: Apr-2019
Date: 2018-12-05
Publication information: Diabetes, Obesity & Metabolism 2019; 21(4): 772-780
Abstract: Low circulating testosterone is associated with an increased risk of developing type 2 diabetes (T2DM) in overweight men with impaired glucose tolerance (IGT). To determine in a multi-centre, double-blinded placebo-controlled randomised 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. Overweight or obese men aged 50-74 years with a serum testosterone of ≤14nmol/L and IGT or newly diagnosed T2DM established by an oral glucose tolerance test (OGTT). Six Australian capital city-based tertiary care centres. Participants were randomised 1:1 and injected with testosterone undecanoate (Reandron, Bayer) (1000mg/4ml) or vehicle (4ml castor oil), at baseline, 6 weeks and 3-monthly thereafter. PRIMARY ENDPOINTS: (1) Proportion of participants with 2-hour OGTT ≥ 11.1 mmol/L at 2 years. (2) A difference at 2 years ≥ 0.6mmol/L in the mean 2-hour OGTT glucose between treatments. 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 utilisation and costs. 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: (i) Changes in bone density and micro-architecture; (ii) motivation and behaviour; (iii) telomere length; (iv) extended treatment up to 4 years, and (v) hypothalamo-pituitary testicular axis recovery at treatment end. This article is protected by copyright. All rights reserved.
DOI: 10.1111/dom.13601
ORCID: 0000-0002-6085-445X
Journal: Diabetes, Obesity & Metabolism
PubMed URL: 30520208
Type: Journal Article
Subjects: Testosterone
body composition
type 2 diabetes mellitus
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