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Diabetes clinical trial

Trial to assess testosterone in preventing T2DM

T4DM trial will enrol up to 1,500 overweight and obese male participants
Lead researcher, Professor Gary Wittert

A clinical trial that will assess whether testosterone treatment can help prevent the development of type 2 diabetes in men who are at high risk of the disease, has been announced by Australian researchers.

The Testosterone 4 the prevention of Diabetes Mellitus (T4DM) trial is a two-year, AUS$4.8 million study, which will involve up to 1,500 overweight and obese male participants.

"We've known for quite a long time that when men become obese, perhaps if there are disturbances of metabolism, that their testosterone level falls," said

lead researcher Professor Gary Wittert, Adelaide University's School of Medicine.  "What we think is occurring is that you get obesity - that's what's causing the risk of diabetes, but the low testosterone causes a feed-forward effect. Now whether the best treatment is weight loss, which increases testosterone, or giving testosterone is the question we're trying to answer."

All the participants will be enrolled in weight loss programmes and receive injections of either testosterone supplements or a placebo every three months. They will then be followed up for two years for incidence of type 2 diabetes.

The exact role of testosterone in the onset of diabetes is unclear, but weight gain in middle-age can cause men to lose testosterone and the motivation to exercise.

Men who sign up for the study will have complimentary access to Weight Watchers and can follow the programme either by attending meetings or online, which is ideal for men who prefer not to attend a weight loss group.

Researchers are currently recruiting men in Sydney, Melbourne, Adelaide and Perth to participate in the study. Men who do not have the diabetes but who have impaired glucose tolerance or pre-diabetes will be eligible to take part in the programme. The inclusion criteria for the trial include:

  • Males aged 50-74 years
  • Waist circumference of 95cm or more
  • No history of prostate cancer
  • No stroke or transient ischemic attack in the past three years
  • No major cardiovascular event in the past six months
  • Blood pressure lower than 160/100 at rest.

"If the trial is successful in the sense that testosterone has benefits, then it is potentially a treatment that could be used more widely provided we can also show that it's safe," said Wittert.

The Institute of Health and Welfare estimates more than 750,000 Australians have type 2 diabetes and thousands more are at risk.

Visit the trial website to learn more about the T4DM clinical trial

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