The T4DM study aims to determine whether testosterone treatment combined with a lifestyle intervention (Weight Watchers®), compared to lifestyle intervention alone, reduces the incidence of Type 2 Diabetes in high-risk, overweight and obese men aged 50 - 74 years.

For further information go to: T4DM.

Trial Summary:

T4DM is a large, multi-centre, phase III, double-blind, placebo-controlled two-year trial of testosterone therapy combined with a lifestyle intervention (Weight Watchers®) compared to the lifestyle intervention alone for the prevention of Type 2 diabetes. The trial is run through six centres in Australian capital cities. Recruitment to the study closed in February 2017 with 1007 participants enrolled. The trial is ongoing and follow-up is due to be completed in May 2019.

Supported By:

NHMRC Project Grant 1030123, Bayer, Lilly, University of Adelaide. Weight Watchers® provided enrolment to their program for trial participants without cost.

Eligibility:

Men aged 50 -74 years, overweight or obese, pre-diabetic or newly diagnosed diabetic and with testosterone ≤14nmol/L.

Registration ID:

ACTRN12612000287831

Participation:

1,007 men were enrolled in the study

Australian Lead Group:

NHMRC CTC

Status:

Closed to recruitment, study treatment on-going

Activation Date:

 

Chairs:

 

Contact:

t4dm@ctc.usyd.edu.au