Testosterone Intervention for the Prevention
of Diabete Mellitus in High Risk Men
Are you male? Aged 50-74? Sign up for T4DM today!
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
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
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
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
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 firstname.lastname@example.org or
call 1300 865 436 to request further information.
Thank you for your support of the T4DM study.