Testosterone Intervention for the Prevention of Diabete Mellitus in High Risk Men

Are you male? Aged 50-74? Sign up for T4DM today!

Frequently Asked Questions

 
 
1. What is type 2 diabetes?  

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.

 

 
 
2. Am I at risk? 

The main risk factors for type 2 diabetes are:
- being older (over 45 years of age)
- being overweight / carrying extra weight around your waist
- family history of diabetes
- having high cholesterol or high blood pressure
- not exercising regularly

It is important to note that these factors can pre-dispose you to developing type 2 diabetes but you can still get diabetes even if you do not have all (or any) of these risk factors.

Click here for more information from Diabetes Australia.

 
 
3. How is type 2 diabetes diagnosed? Are there any symptoms? 

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.

 
 
4. What is the T4DM study?  

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.

 
 
5. Can I join the T4DM study? 

Yes, you can! We are looking for men aged 50 -74 years who live in NSW, Victoria, Queensland, South Australia or Western Australia. You first need to complete our online questionnaire to check whether the study will suit you. Contact us on askt4dm@ctc.usyd.edu.au or 1300 865 436.

For more information on joining click here.

 
 
6. Why join the T4DM study? 

There are plenty of great reasons:
- to check whether you have pre-diabetes
- to check whether you have low or normal testosterone levels
- to receive 2 years of treatment with either testosterone or placebo free of charge
- to receive 2 years access to Weight Watchers free of charge
- to receive free regular health checks and monitoring from the study nurses and doctors
- to help us find out if testosterone can prevent type 2 diabetes

Of course, as with all medical treatments there are not only benefits but also risks to consider and you can read about them here. You will also be able to discuss any possible risks with your study nurse and doctor before enrolling in the study. The study has been approved by an ethics committee at each study site.

 
 
7. Why do I need to fill in the questionnaire to join the study? 

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.

 
 
8. What will happen if I decide to complete online questionnaire? 

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.

 
 
9. What if I don’t have internet access or don’t want to complete the questionnaire online? 

If you aren't able to complete the questionnaire online you can call the T4DM team on 1300 865 436 and answer the questions over the phone. Another option is to complete our contact form and we will contact you.

 
 
10. What should I do if I have technical problems with the online questionnaire? 

If you have any issues please let us know by clicking the contact form and we will contact you.

 
 
11. How do I measure my waist? 

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.

Click here for a great, short youtube clip showing how it is done.

To measure your waist, you will need a tape measure.

  • Remove your shirt
  • Find your waist; it is halfway between the bottom of your rib cage and your hip bone.
  • Pass the tape measure around your stomach at the level of your waist. Make sure the tape measure is flat and not twisted.
  • Breath out/relax and take your measurement.
  • To be accurate it is best to repeat the measurement and make sure you get the same answer.

N.B. Your waist circumference is NOT measured around your hips/where the waistband of your trousers sits.

 
 
12. What will happen if I choose to have the screening blood tests? 

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.

 
 
13. Where can I have my blood test done? 

You can attend any collection centre run by one of the following companies:

- Douglass Hanly Moir (New South Wales)
- Melbourne Pathology (Victoria)
- Sullivan Nicolaides Pathology (Queensland)
- Clinpath (South Australia)
- Clinipath (Western Australia)

There are many collection centres to choose from and hopefully there is one near you.

To see a full list of locations click here and choose your state or give us a call and we can help you find the best location for you 1300 865 436.

 
 
14. What is the Oral Glucose Tolerance Test (OGTT)? 

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.

 
 
15. What is 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.

 
 
16. What treatment is there for prediabetes? 

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.

 

 
 
17. Why will you test my testosterone levels? 

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.

 
 
18. Could I have low testosterone? 

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.

 
 
19. What will happen to my blood test results? 

Your pathology laboratory will send you a copy of your blood test results. We will also write to you by email or post to let you know whether your results show that you are eligible to join the study.

We use your results to check whether the study might suit you; we look at your 2 hour glucose level (to check for pre-diabetes), your testosterone level as well as your general health.

If your results show that you may be eligible for the study, a nurse from your local T4DM study clinic will contact you to arrange an appointment.

Your blood test results will be stored securely and will not be shared with anyone outside the T4DM study team unless required by law.

If you have concerns about your results please talk to to your local GP or contact us.

 
 
20. What treatment will I receive on the study? 

All T4DM participants receive free access to Weight Watchers. This includes access to Weight Watchers meetings as well as the online tools, trackers and forums. As well as access to Weight Watchers, participants receive either testosterone or placebo treatment. Neither you nor your study doctor will know whether you are receiving testosterone or placebo.
The treatment will be given as an injection at enrolment, 6 weeks later and then every 12 weeks for 2 to 4 years. If you are interested in joining the study, your study nurse or doctor will explain exactly what is involved with the treatment and any expected side-effects. There is also some information on side effects here.

 
 
21. Why testosterone? 

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.

 
 
22. What does double-blind mean? 

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.

 
 
23. What is placebo? 

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.

 
 
24. What is a digital rectal exam and why will I need one if I’d like to join the T4DM study? 
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.
 
 
25. Who is running this study?  
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.
 
 
26. Where are the participating hospitals? 

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

 
 
27. Where can I get more information? 

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.

 
 
28. Are there any risks to participating? 

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.

 
 
29. What next? 

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.

Start your questionnaire here.

 
 
30. Will I be paid to participate? 

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.

 
 
31. Can I print another copy of my screening consent form? 

Yes, the web version of the screening information consent form can be found here:

Prescreening Information and Consent Form

 
 
32. Want to know more? 

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

 

 
 
33. Why was I not eligible? 

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:

  • They are already diabetic. Our study is investigating prevention of diabetes and therefore if you are already diabetic the study will not suit you.
  • They have had cancer
  • They have had treatment for abnormal heart rhythms
  • They have had a heart attack or other major cardiac event in the past 6 months
  • They have a personal or family history of blood clots
  • Their waist circumference is less than 95cm

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:

  • Because we are concerned that the treatment may not be safe for them, or
  • Because we think that including them may make it difficult to generalise the results from the study or may make our results more difficult to interpret.

If you have concerns or believe that you should have been eligible please do contact us. We're happy to review your case.

 
 
34. Are you still accepting new participants? 

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.