Influence of the Aromatase Inhibitor Letrozole on Heart and Liver Function in Obese Men
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- cardiac function parameters
研究概览
简要总结
It seems plausible that increased aromatase activity in obese men, as a result of a larger fat mass, is responsible for decreased levels of testosterone. Therefore aromatase inhibition increases testosterone levels, which may affect hepatic and cardiac function.
In this intervention study two groups of hypogonadal obese men are compared. Group A is treated with Letrozole 2.5 mg (aromatase inhibitor) once every two days during four months; a group with normal testosterone and low oestrogen concentrations. Group B is treated with placebo once every two days during four months; this group will retain low testosterone - and high oestrogenic concentrations.
The primary objective of the study is to evaluate effects of changed sex steroids in obese men on hepatic and cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Obese male subjects
- •Planned for gastric bypass (BMI > 30 kg/m²)
- •low testosterone levels
- •age between 20 and 65
排除标准
- •Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumours, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
- •Treatment with corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
- •Impaired renal function defined as serum-creatine > 1.5 mg/dL
- •Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator
- •Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial
- •Palpable prostate nodule or induration, Prostate-specific antigen (PSA) > 3 ng/mL, prostatism, untreated sleep apnea syndrome, erythrocytosis (hematocrit > 50%) or hyperviscosity. (cfr. Endocrine Society Clinical Practice Guideline by Bhasin S et al.)
- •Known or suspected abuse of alcohol or narcotics
研究组 & 干预措施
Letrozole
干预措施: Letrozole (Drug)
Placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
cardiac function parameters
时间窗: before intervention
heart function will be measured by echocardiography.
Hepatic function parameters
时间窗: after 4 months intervention
Baseline sex steroids will be measured by Liquid chromatography-mass spectrometry (LC-MS/MS) in fasting blood samples, before 10:00 am. Liver function will be analysed by a Nuclear Magnetic Resonance (NMR) recording
次要结局
- glucose metabolism(Before intervention.)
- weight(after four months intervention.)