What is the T4DM study?
T4DM (Testosterone for the prevention of Diabetes Mellitus) is a randomised, double -blind, placebo-controlled trial that aims to determine whether testosterone treatment combined with lifestyle change can prevent type 2 diabetes in overweight men aged 50 to 74 who have pre-diabetes and low serum testosterone.
This is a multicentre study run by the University of Adelaide and coordinated by the NHMRC Clinical Trials Centre at the University of Sydney. The study is funded by an NHMRC grant.
We are inviting GPs to support the study by displaying a study poster in their waiting room. GPs can also refer their patients to the study (see” How can my patient join?” below)
What treatment do participants receive?
Participants are randomised to receive 3-monthly intramuscular injection of either testosterone undecanoate 1000mg or matched placebo.
All participants also receive a 2 year Weight Watchers membership. Participants can choose between online or group coaching. This membership is provided at no charge to the participant.
Who can join?
Participation is open to men aged 50-74 who have a waist circumference of 95cm or more. Participants must not have been previously diagnosed with Type 2 Diabetes.
As part of our screening process we will check participants’ glucose and testosterone levels and men with pre-diabetes (or newly diagnosed diabetes) and lower than normal testosterone (≤14.0nmol/L) will be invited to enrol in the study.
Where are our study clinics?
Study participants are treated at 6 dedicated T4DM study clinics across Australia.
What about safety and side effects?
Participant safety is closely monitored by study sites. All potential participants receive a full medical history and clinical assessment prior to study enrolment. Men with high PSA or serious cardiac issues are not eligible to join the study. Once enrolled, all participants receive 3-monthly blood sugar level monitoring. Participants’ liver function, PSA and other blood indicators are also regularly monitored.
You can request copies of your patient’s on-study blood test results throughout the study.
Will I be informed if my patient joins the study?
Yes, our study clinic will write to you to let you know if your patient joins the study. We will stay in contact with you about any matters of concern related to your patient.
How can my patient join the study?
There are 3 easy ways to join the study:
How can I find out more?
Click here to download a copy of the Patient Information and Consent Form.
Email [email protected] or call 1300 825 498 to request further information.
Thank you for your support of the T4DM study.
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