Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism: Metabolic and Cardiovascular Effects.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Total Testosterone
研究概览
简要总结
Hypogonadism is a clinical condition that can be associated with obesity in man. Controversy exists regarding if its a condition that needs to be treated. The standard Testosterone Therapy is associated with increase in cardiovascular risks, according to some studies, and leads to infertility. The use of Clomiphene Citrate in this sub population of obese man as an alternative treatment option is not well studied. The aim of this protocol is to evaluate the cardiovascular risks, metabolic and hormonal parameters in a double blinded randomized placebo trial.
详细描述
Hypogonadism (low testosterone level) in obese man is a clinical condition which treatment is controversial. Most of this controversy remains regarding the association between cardiovascular risk elevation and Testosterone replacement therapy in some studies.
This protocol is a double blinded randomized placebo trial and 2 groups will be followed. The primary end-point of this research is the correlation between the serum testosterone and flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, sVCAM-1, E-selectin and progenitor endothelial cells.
The secondary end-points include:
(1) the evaluation of metabolic parameters: weight, abdominal circumference, glycaemia, total cholesterol, fractions and triglycerides, homeostasis model assessment index (HOMA) and bioelectrical impedance parameters; and (2) hormonal parameters: total testosterone levels, sex hormone-binding globulin (SHBG), Luteinizing Hormone (LH) , Follicle stimulating hormone (FSH) and Estradiol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
randomized, double blinded, placebo-controlled, parallel group, single-center study
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ADAM questionnaire positive for 3 or more questions
- •Total serum Testosterone lower than 300 ng/dL in two different occasions, within a 1-week minimum interval. This blood sample must be collected between 8 and 11 a.m.
- •Low or Inappropriate normal serum Luteinizing hormone (LH) level
- •ATP III Metabolic Syndrome Criteria
- •Obesity - BMI over 30 kg/m2
排除标准
- •Systemic illness, such Rheumatoid Arthritis, Cushing disease, liver insufficiency or renal insufficiency. -Use of certain medications (opiates, high-dose glucocorticoid therapy, methadone)
- •Eating disorders
- •Testicular volume below 4 mL
- •Use of recreational drugs
- •Excessive exercise practice
- •Men in treatment for prostatic cancer
- •Hyperprolactinaemia
- •Hemochromatosis
- •History of headache
- •Systolic blood pressure lower than 100 mmHg
- •Previous adverse reactions to nitrate compounds
- •Diabetes over 10 years of diagnosis
研究组 & 干预措施
Placebo
One pill every other day during 12 weeks
干预措施: Placebo (Drug)
Clomiphene Citrate
Clomiphene citrate 50 mg orally daily (Serophene) during 12 weeks
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
Total Testosterone
时间窗: baseline up to 12 weeks
electrochemical luminescence analysis in blood sample
Endothelial Function
时间窗: baseline up to 12 weeks
1. Flow-mediated dilatation of the brachial artery (FMDAB): Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. 2. Icam, vcam and selectin 3. Endothelial progenitor cels
次要结局
未报告次要终点
研究者
Cintia Cercato
MD
University of Sao Paulo