Type 2 diabetes is a condition where the body is resistant to the effects of a hormone called insulin, made in the pancreas. The pancreas can’t make enough insulin to overcome this resistance.
Insulin is used by your body to keep you blood sugar levels steady. It is also important for building protein and preventing the breakdown of fat.
If there is not enough insulin to meet these requirements, blood sugar levels increase along with blood fat levels and muscles breakdown.
In its very early stages type 2 diabetes can only be diagnosed by a blood test but later on health problems such as fatigue, weakness, thirst, frequent urination, blurred vision and weight loss may occur.
Often it is only diagnosed after blood sugar has been high for many years and damage to the kidneys, blood vessels, nerves, heart, and eyes have occurred.
There is a strong genetic component to type 2 diabetes which means that it tends to run in families. But even then it is much more likely to occur, or occur at a much earlier age, in people who become obese and/or have a sedentary lifestyle.
In its very early stages, a blood test is needed to diagnose type 2 diabetes. Later on symptoms such as fatigue, weakness, thirst, frequent urination, blurred vision and weight loss may occur. Often diabetes is only diagnosed after blood sugar has been elevated for many years and damage to the kidneys, blood vessels, nerves, heart, and eyes have occurred.
The T4DM study is a clinical trial trying to discover whether testosterone treatment combined with a lifestyle program can prevent type 2 diabetes in men with pre-diabetes and low testosterone.
We need to ensure the study will be suitable and safe for you. If your answers indicate the study may suit you we will ask you to go for a blood test to see whether you have prediabetes, to measure your testosterone and to assess your general health.
Completing the questionnaire takes about 10 minutes. You will be asked about your general health and well-being as well as about any medications you take. We will also need your contact details so we can get in touch if you are eligible.
Your details will be stored securely and confidentially and will not be shared with anyone except the study team. If it turns out you are not eligible for the study then all your identifying details (for example your name, email address and DOB) will be deleted. If the questionnaire shows that the T4DM study might be right for you then you will be asked to get some blood tests done.
If you have any issues please let us know by clicking the contact form and we will contact you.
One of the important criteria for joining the T4DM study is waist circumference. We will be enrolling men who are overweight or obese and this is defined as having a waist circumference of 95cm or more.
To measure your waist, you will need a tape measure.
N.B. Your waist circumference is NOT measured around your hips/where the waistband of your trousers sits.
The blood tests will be done at your local pathology centre and take around 2 hours. We use the blood tests to check your glucose and testosterone levels and your general health.
The test to check your glucose level is called an Oral Glucose Tolerance Test (OGTT), you can read more about this below.
You need to fast (not eat or drink other than water) from midnight the night before your blood test so we encourage people to have their test before 10am.
An OGTT is a blood test to check your glucose levels over time. You will have some blood collected and then be given a glucose drink which tastes like sweet lemonade. Your blood will be taken again 2 hours after the drink to check what effect the glucose had on your blood glucose levels. Some centres also a take a 1 hour sample. The OGTT is the most effect way to check whether you have diabetes or prediabetes.
Before people develop type 2 diabetes, they almost always have “prediabetes” which means blood glucose levels are higher than normal but not yet high enough to be diagnosed as diabetes. Recent research has shown that long-term damage to the body, especially the heart and circulatory system, may occur in people with prediabetes.
Some studies estimate that 10-25% of people in Western Countries may have prediabetes.
However, the good news is that appropriate intervention at the prediabetes stage can prevent progression to diabetes.
If you decide to join the T4DM study we will check to see whether or not you have prediabetes. The study will enrol men who have prediabetes to see whether treating them with testosterone can reduce the chance of their prediabetes turning into diabetes.
Prediabetes can be treated through lifestyle changes and weight loss of around 5 to 7%. Research has shown that a healthy eating plan, in combination with a small reduction in eating and regular exercise (such as regular walking) can help people achieve this loss.
A medication called metformin has also been shown to have some benefit but it is nowhere near as good as lifestyle change. Because lifestyle change is so effective we are offering all men who participate in the study 2 years’ access to Weight Watchers to help them achieve this change.
Testosterone is the main male sex hormone and it is important for maintaining normal sexual function, muscle strength and energy level. Testosterone is often low in men who are overweight or obese men, particularly if they have prediabetes and are over 45. These men are at very high risk of developing full-blown diabetes. We want to learn whether giving men with low testosterone and prediabetes testosterone treatment reduces their risk of developing diabetes.
If you have low sex drive, problems with erections, loss of energy, strength or endurance or have a feeling of being flat or unmotivated then maybe you do have low testosterone. However these are general symptoms and the only way to properly diagnose low testosterone is by a blood test.
Testosterone is a male hormone that is currently used to treat men whose bodies do not produce enough of their own. Low levels of testosterone are linked to a higher risk of developing type 2 diabetes, however, it is not yet known whether testosterone treatment can prevent type 2 diabetes. The T4DM study aims to find out whether testosterone can help prevent diabetes in men with prediabetes and low testosterone.
This means that neither the participant, study doctor nor study staff know whether a person is receiving the testosterone (active) treatment or placebo (inactive) treatment. Both treatments look the same and are administered in the same way.
A placebo is an inactive (or dummy) treatment. It looks exactly like the active treatment but does not contain the active ingredient. A placebo is used in clinical research to help ensure that the thereapeutic benefit of a new treatment is measured as accurately as possible.
A digital rectal exam is a simple and quick procedures for checking your prostate. It is important that the doctor checks that your prostate is normal before starting you on study treatment.
The T4DM study is being run by the University of Adelaide using funds awarded by the NHMRC (National Health and Medical Research Council). The study is being coordinated by the NHMRC Clinical Trials Centre and the University of Sydney.
The following hospitals/clinics are involved:
Sydney
Anzac Research Institute, Concord Hospital, Concord
Melbourne
The Austin Hospital, Heidelberg
Brisbane
Princess Alexandra Hospital, Woolloongabba
Adelaide
Queen Elizabeth Hospital, Woodville
Perth
Keogh Institute of Medical Research, Sir Charles Gairdner Hospital, Nedlands
Fiona Stanley Hospital, Murdoch
You can get more information by watching our videos or by calling our information line on 1300 865 436 (for the cost of a local call). If you would like specific advice on your health and your risk of diabetes please contact your local doctor.
Although testosterone injection is a routinely prescribed medicine, side effects may occur in some people. The most frequently reported side effects are acne or pain at the injection site, as well as a cough for a short time following an injection. Men also sometimes experience a temporary reduction in sperm count. This effect is reversible but may take months to wear off completely. The treatments in this study are not expected to have any detrimental effect on your sexual function.
Before joining the study you will be able to discuss all side effects, common and uncommon, with the study nurse and doctor and you will be given a patient information sheet to take away and read which provides details on the risks and benefits of treatment as well as other information about the study and your participation. Click here to download the patient information sheet.
Study participation is voluntary. You can withdraw from the study at any time you choose simply by informing the study team.
If you would like to join the study there are 3 steps to check whether T4DM might be right for you:
1. Complete the online questionnaire
2. Get some screening blood tests
3. Attend a study clinic for a final check before joining the study.
Remember, you can change your mind at any time and completing the questionnaire does not commit you to joining the study.
No, you will not be paid to participate. However participants will receive free access to Weight Watchers for the course of the study and free study treatments with either testosterone or placebo.
Yes, the web version of the screening information consent form can be found here:
If you would like to learn more about the study you can download our patient information sheets below. These sheets provide more detail on the process involved in joining the T4DM study and also what is involved once you are on the study.
These documents are given to all participants before they join the study but you’ll be getting ahead of the game by reading them here first! If you do decide to join the study you’ll have the opportunity to discuss this information in detail with your study doctor or study nurse. They will answer any questions you may have. You can also contact us for more information.
Information about the screening process
This is the process we will use to determine whether joining T4DM might be right for you.
Click here to download
Information about being part of the study
This information sheet explains what is involved if you join the study. It provides more details on the assessments and treatments you will receive as well as the expected risks and benefits.
Click here to download
If you were filling in our questionnaire and were told you weren’t eligible you may want to know why.
Firstly, thanks for taking the time to fill in the questionnaire. We’re sorry you weren’t eligible to join the study.
The most common reasons that men are not eligible to join the study are:
These are the most common reasons but there are others. If you are still not sure why you were ineligible please contact us and we can provide more information.
Why do we need to exclude anyone from the study?
The two main reasons that we can’t include all men in our study are:
If you have concerns or believe that you should have been eligible please do contact us. We’re happy to review your case.
Yes we are! The study has been open since 2013 and we hope to close to recruitment in 2016. It isn’t too late to get involved.
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