Participants Required for Trial on Testosterone Shots and Diabetes Prevention
Monday, 17 March, 2014
University of Sydney researchers are seeking male participants for a novel trial assessing whether regular testosterone shots can prevent type 2 diabetes in men.
The $4.8 million Testosterone for the prevention of Diabetes Mellitus (T4DM) study – the first of its kind in the world – is looking at the potential benefits of treating men with early signs of the condition (pre-diabetes) with testosterone supplements in conjunction with a dedicated weight-loss program.
The researchers are seeking up to 1500 overweight male participants aged 50-74 for this ground-breaking study ranging across NSW, Victoria, South Australia and Western Australia.
Lead investigator, Associate Professor Ann Conway, said men who sign up for the study would have free access to the online weight-loss program run by Weight Watchers.
“An online program is ideal for men who prefer not to attend Weight Watchers meetings,” she said.
“The T4DM trial will look into whether diet and testosterone can prevent type 2 diabetes in men who have prediabetes and relatively low testosterone.
“We will be recruiting 1500 men who do not yet have diabetes across Australia to join the study, people who exhibit pre-diabetes conditions, such as being overweight around the middle.
“Study participation will last approximately two years and participants will receive free access to Weight Watchers and treatment with either testosterone or placebo.
"By giving testosterone supplements to men in that critical pre-diabetes stage, and by putting them on a dedicated weight-loss program, we hope to see sustained reductions in weight and a reduced chance to develop type 2 diabetes.
“Older men who have developed a large belly and are at risk of diabetes now have an opportunity to do something about their weight, improve their lives, and provide us with all-important research results that could benefit many others in the future."
Dr Conway said in the first six months of study participation, 77 per cent of men lost weight.
“And 83 per cent of men reported that they were getting up at least once at night to urinate before they joined the study. The study participants said this is a very important issue to them, many said it was this problem that motivated them to join the study and take steps to improve their health.
“After only six months of study participation 22 per cent of participants have already reported that they are getting up less often or are not getting up at all and we hope to see this improve further as the study continues.”
Trial participant Michael Pryke signed up because he knew he was at high risk of developing type 2 diabetes, given combined factors of lifestyle, weight and a lack of exercise.
“My wife works hard on her own health and on our dietary habits, but I have lacked the necessary motivation to really do something,” he said. “This study has provided the impetus to finally make the long term life style changes I know I should be implementing, while offering an opportunity to contribute to ongoing research in this area.”
To potential trial participants, Mr Pryke said: “Go for it – you have nothing to lose and an enormous amount to gain. “Proving the role of testosterone in weight loss will be important and I believe publicity around the positive impacts on the lives of the men who actively participate will have a broader impact.”
To participate, call 1300 865 436 or visit http://www.diabetesprevention.org.au/
This study is funded by the National Health and Medical Research Council (NHMRC).
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