ACTRN12612000287831已完成3 期
Will testosterone treatment 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?
niversity of Adelaide0 个研究点目标入组 1,000 人开始时间: 2012年3月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 74 Years（—）
- 性别
- Male
入选标准
- •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
排除标准
- •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
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