None listed
Conditions
Brief summary
The T4DM study will investigate whether treatment with testosterone in combination with a lifestyle program normalise glucose tolerance in men with either pre-diabetes or newly diagnosed type 2 diabetes, in comparison to placebo and a lifestyle program in men aged 50-74 years. See www.t4dm.org.au for details
Interventions
Testosterone treatment comprising 1000mg testosterone undecanoate administered by intramuscular injection at enrolment, 6 weeks and subsequently at 3-monthly intervals for 2-4 years. The trial will have 2 years of recruitment and then a further 2 years of treatment and follow-up. In general, each individual's treatment duration will be determined by when in the recruitment period they join the study. Weight Watchers membership. Weight Watchers is a lifestyle program which involves face-to-face m
Testosterone treatment comprising 1000mg testosterone undecanoate administered by intramuscular injection at enrolment, 6 weeks and subsequently at 3-monthly intervals for 2-4 years. The trial will have 2 years of recruitment and then a further 2 years of treatment and follow-up. In general, each individual's treatment duration will be determined by when in the recruitment period they join the study. Weight Watchers membership. Weight Watchers is a lifestyle program which involves face-to-face meetings and/or access to the on-line program. It provides guidance on healthly eating and exercise. Participants who choose the meeting option will be requested to attend a weekly meeting. The program also involves diarising of food intake and exercise. Weight Watchers membership will start at enrolment and last for 2 years. Participants will be encouraged to participate in this program and will be asked about their compliance at each study visit. Study visits occur at 6 weeks after enrolment and then every 3 months for 2 to 4 years as described above. For more details see www.t4dm.org.au T4Bone sub-study: Up to 160 participants enrolled at Austin Hospital will have additional CT scan, DEXA scan and blood sample taken every 12 months for two years to assess the impact of the testosterone intervention on bone density, microarchitecture and turnover. T4Mood and Behaviour (T4MB)sub-study: All T4DM participants from Fiona Stanley Hospital, Queen Elizabeth Hospital, Austin Hospital and Princess Alexandra Hospital are also enrolled onto the T4MB substudy. This sub-study involves completion of a one-page questionnaire at baseline and every 6 months until 3 months after treatment end. Reminder sub-study: Up to 540 men who are registered for the T4DM study but do not attend for lab screening within 4 weeks of registration will be randomised to receive a reminder to attend for lab screening by either text message or phone call. A further reminder at 8 weeks will be sent if they have still not attended for lab screening. Telomere Length sub-study: Up to 900 participants will have an additional whole blood sample collected at the 2 year visit. Telomere length will be measured in whole blood at baseline, and at two years. Screening process evaluation sub-study: Prospective participants of the T4DM study will be invited to take part in the screening process evaluation sub-study. Participants will be eligible to take part if the they are enrolled in the main study or decline the main study from June - December 2016. Participants who have not completed lab screening at the close of recruitment in December 2016 will also be eligible. Participation in the sub-study will involve completion of a 5-10 minute online questionnaire followed by a 10 minute telephone interview for a sub-group of participants. The sub-group will be selected based on willingness and principles of theoretical sampling. The online questionnaire and phone interviews will collect information participants preferences and feedback with regards to the screening process for the T4DM study. T4DM Run-off sub-study: Up to 700 participants who are enrolled on the T4DM study and have completed study treatment after January 2015 will attend for 7 visits after completing study treatment. This sub-study involves completion of quality of life questionnaires, collection of serum and whole blood samples and assessment of weight and concomitant medications. Newsletter sub-study: Up to 950 T4DM study participants (either currently on study treatment or completed study treatment) will be randomly allocated to receive one of eight possible email newsletter messages using a factorial design. Variables to be evaluated are subject line (standard vs enhanced), sender characteristics (generic vs nurse) and addressee (generic vs personalised).
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
50 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Men aged 50 – 74 years Abdominal obesity (waist circumference greater than or equal to 95cm) Serum testosterone levels of less than or equal to 14 nmol/L At screening visit, a 2hr plasma glucose greater than or equal to 7.8 and less than or equal to 15 mmol/L in response to a 75 g oral glucose tolerance test (OGTT) Willing to participate in a lifestyle program co-ordinated by Weight Watchers Able and willing to meet all protocol-required procedures and visits Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in study
Exclusion criteria
Testosterone treatment in the past 12 months Baseline T less than 8 nmol/L , except where the participant has been assessed by a study investigator and all causes of low testosterone other than obesity have been ruled out. Previously diagnosed Type 2 Diabetes Symptoms indicating a requirement for specific pharmacotherapy for diabetes Use of any medication known to affect testosterone or SHBG within the previous 1 month or with an underlying condition where there is an appreciable possibility that these may be required within the next 2 years. Includes medications which: Affect the production (e.g. opiates, GnRH agonists) or action (e.g. spironolactone) of androgens Affect the production of Sex Hormone Binding Globulin (SHBG) (e.g. thyroxine, insulin, growth hormone, antiepileptics):- please note thyroxine permitted if the dose has been stable for at least 3 months and will remain so. Significant hypothalamo-pituitary gonadal (HPG) pathology likely to require treatment with T, excluding cryptorchidism, torsion, orchitis, well-treated hemochromatosis. Ongoing episode of major depression or other significant psychiatric disorder Prior history of prostate cancer or : Greater than upper limit of normal for age-adjusted PSA values Clinical suspicion of malignancy on digital rectal examination (DRE) Score of greater than 19 on the IPSS (Q1-7), indicating severe symptoms of Benign Prostatic Hyperplasia (BPH) Breast, liver cancer or other malignancy, except for non-melanomatous carcinoma of the skin, which could affect compliance with the protocol or interpretation of study results Significant personal or first-degree family history of thrombophilia, or taking anticoagulants other than low dose Aspirin (<150mg) and/or clopidogrel Known to be human immunodeficiency virus ( HIV) positive Major cardiovascular event within the previous 6 months, or active cardiac disease defined as one or more of the following: New York Heart Association functional classification of heart failure greater than or equal to 2 (See Appendix II) or symptomatic angina Uncontrolled arrhythmias, or arrhythmias deemed clinically significant by the investigator Myocardial infarction , cardiac stenting or angioplasty in past 6 months Transient Ischaemic Attack (TIA) or stroke within the previous 3 years Elevated blood pressure (greater than 160 systolic and greater than 100mmHg diastolic) at screening Haematocrit greater than 50% Abnormal liver function: ALT, GGT, Bilirubin or ALP greater than 3 times upper limit of normal (ULN) Known chronic viral hepatitis eGFR less than 30 mL/minute Clinically significant non-malignant disease that is likely to lead to serious illness or death within 2 years, or in the opinion of the Clinical Investigator, requires other intervention Previous or planned bariatric surgery Treatment with anti-obesity drugs or any investigational medication within 6 months prior to informed consent Known history of anabolic steroid, drug or alcohol abuse within 6 months prior to the time of screening
Outcome results
None listed