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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.
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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. |
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Supported By: |
NHMRC Project Grant 1030123, Bayer, Lilly, University of Adelaide. Weight Watchers® provided enrolment to their program for trial participants without cost. |
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Eligibility: |
Men aged 50 -74 years, overweight or obese, pre-diabetic or newly diagnosed diabetic and with testosterone ≤14nmol/L. |
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Registration ID: |
ACTRN12612000287831 |
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Participation: |
1,007 men were enrolled in the study |
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Australian Lead Group: |
NHMRC CTC |
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Status: |
Closed to recruitment, study treatment on-going |
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Activation Date: |
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Chairs: |
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Contact: |