{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:48:16Z","timestamp":1787014096726,"version":"build-2736575974"},"reference-count":48,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,1,4]],"date-time":"2019-01-04T00:00:00Z","timestamp":1546560000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["1030123"],"award-info":[{"award-number":["1030123"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001786","name":"University of Adelaide","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001786","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Low circulating testosterone is associated with an increased risk of developing type 2 diabetes (T2DM) in overweight men with impaired glucose tolerance (IGT).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To determine in a multi\u2010centre, double\u2010blinded placebo\u2010controlled 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\u2009years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study population<\/jats:title>\n                    <jats:p>Overweight or obese men aged 50\u201074\u2009years with a serum testosterone of \u226414\u2009nmol\/L and IGT or newly diagnosed T2DM established by an oral glucose tolerance test (OGTT).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting, drug and protocol<\/jats:title>\n                    <jats:p>Six Australian capital city\u2010based tertiary care centres. Participants were randomized 1:1 and injected with testosterone undecanoate (1000\u2009mg\/4 mL) or vehicle (4 mL castor oil), at baseline, 6 weeks and 3\u2010monthly thereafter.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary endpoints<\/jats:title>\n                    <jats:p>(a) Proportion of participants with 2\u2010hour OGTT \u226511.1 mmol\/L at 2 years, and (b) a difference at 2 years \u22650.6 mmol\/L in the mean 2\u2010hour OGTT glucose between treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Secondary endpoints<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Safety<\/jats:title>\n                    <jats:p>Overseen by an Independent Data Safety Monitoring Committee. Haematocrit, lipids and prostate\u2010specific antigen (PSA) are assessed 6\u2010monthly and information relating to haematological, urological and cardiovascular adverse events from each clinic visit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Sub\u2010studies<\/jats:title>\n                    <jats:p>(a) Changes in bone density and micro\u2010architecture, (b) motivation and behaviour, (c) telomere length, (d) extended treatment up to 4 years, and (e) hypothalamo\u2010pituitary testicular axis recovery at treatment end.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13601","type":"journal-article","created":{"date-parts":[[2018,12,5]],"date-time":"2018-12-05T22:33:35Z","timestamp":1544049215000},"page":"772-780","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Testosterone therapy to prevent type 2 diabetes mellitus in at\u2010risk men (T4DM): Design and implementation of a double\u2010blind randomized controlled trial"],"prefix":"10.1111","volume":"21","author":[{"given":"Gary","family":"Wittert","sequence":"first","affiliation":[{"name":"Freemasons Foundation Centre for Mens Health School of Medicine, University of Adelaide  Adelaide South Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan","family":"Atlantis","sequence":"additional","affiliation":[{"name":"Freemasons Foundation Centre for Mens Health School of Medicine, University of Adelaide  Adelaide South Australia Australia"},{"name":"School of Nursing and Midwifery Western Sydney University  Penrith Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn","family":"Allan","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, Hudson Institute of Medical Research  Melbourne 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