Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial
Gary Wittert, Karen Bracken, Kristy P Robledo, Mathis Grossmann, Bu B Yeap, David J Handelsman, Bronwyn Stuckey, Ann Conway, Warrick Inder, Robert McLachlan, Carolyn Allan, David Jesudason, Mark Ng Tang Fui, Wendy Hague, Alicia Jenkins, Mark Daniel, Val Gebski, Anthony Keech
The Lancet Diabetes & Endocrinology | ELSEVIER SCIENCE INC | Published : 2021
BACKGROUND: Men who are overweight or obese frequently have low serum testosterone concentrations, which are associated with increased risk of type 2 diabetes. We aimed to determine whether testosterone treatment prevents progression to or reverses early type 2 diabetes, beyond the effects of a community-based lifestyle programme. METHODS: T4DM was a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial done at six Australian tertiary care centres. Men aged 50-74 years, with a waist circumference of 95 cm or higher, a serum testosterone concentration of 14·0 nmol/L or lower but without pathological hypogonadism, and impaired glucose tolerance (oral glucose tolerance test [OGTT..View full abstract
Awarded by Australian NHMRC
This study was funded by the Australian NHMRC (project grant 1030123), Bayer, Eli Lilly, arid the Freemasons Centre for Male Health and Wellbeing at the University of Adelaide. WW (formerly Weight Watchers) provided access to the lifestyle intervention at no cost. Bayer provided the testosterone and matching placebo used in the study at no cost. We thank the T4 DM sturdy participants; Sonic Healthcare (Australia); and the study nurses, Glenda Eraser (ANZAC Research Institute and Concord Hospital, Sydney, NSW, Australia), Jenny Healy (Austin Hospital, Melbourne, VIC, Australia), Helen Daniels and Chyn Soh (Fremantle Hospital and Fiona Stanley Hospital, both in Perth, WA, Australia), Jody Sawyer (Princess Alexandra Hospital, Brisbane, QLD, Australia), Rosemary Cox arid Fiona Cossey (Queen Elizabeth Hospital, Adelaide, SA, Australia), and Lee Mahoney (Keogh Institute for Medical Research, Perth, WA, Australia). We also thank Simone Marschner, Andrzej Januszewski, Caitlin Van Hoist Pellekaan, Cecilia Thing, and Sandra Healey for their contribution to central coordination of the study at the NHMRC Clinical Trials Centre (University of Sydney, Sydney, NSW, Australia), Margaret McGee (University of Adelaide, Adelaide, SA, Australia(for providing administrative and project support in the trial, arid Sue Manley (University of Adelaide, Adelaide, SA, Australia) for her initial clinical 1 coordination at Queen Elizabeth Hospital site, Adelaide, SA, Australia.