A 2-year, multi-centre double-blind, randomised, placebo-controlled trial to determine in men with total testosterone equal to or less than 14nmol/L the efficacy of testosterone treatment together with a lifestyle program in comparison to a lifestyle program alone, to normalise glucose tolerance in those with newly diagnosed type 2 diabetes (T2DM) or prevent progression to T2DM in those with pre-diabetes.

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12612000287831
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-12
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 1000

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-hour glucose on OGTT in the non-diabetic range range (<11.1mmol/L on 75g OGTT) at 2 years.[2 years from baseline];Change in 2 hour glucose at 2 years from baseline[2 years from baseline]