EUCTR2011-000439-10-IT进行中（未招募）不适用
Effect of metformin and clomiphene in obese hypogonadal men with or without type 2 diabetes on plasma levels of testosterone and metabolic parameters
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2012年3月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •males aged between 35 and 55 years
- •Obesity, defined according to the WHO criteria for body mass index (BMI)superior to 30 kg/m2
- •diagnosis of diabetes or impaired glucose tolerance according to the criteria defined by the American Diabetes Association (ADA) in 2009: in particular will be considered to have impaired glucose tolerance subjects with glucose at the second hour after oral glucose tolerance test (OGTT ) between 140 and 199 mg /dl, and diabetic subjects with fasting glucose superior to 126 mg /dl or blood glucose at the second hour after oral glucose tolerance test (OGTT)superior to 200 mg /dl
- •HbA1c inferior to 8.5%
- •metabolic syndrome, defined according to ATP III guidelines, or to the simultaneous presence of three or more of the following disorders: central obesity (waist circumference superior/egual to 102 cm), hypertension (SBP superior/egual to 130 mmHg or DBP superior/egual to 85 mmHg or pharmacological therapy for hypertension), hypertriglyceridemia (superior/egual to 150 mg /dl or pharmacological therapy hypertriglyceridemia), low HDL cholesterol (inferior to 40 mg /dl or pharmacological therapy for low HDL cholesterol
- •hypogonadism, defined for circulating levels of total testosterone inferior/egual to 3 ng /ml
- •signature of informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with primary or secondary hypogonadism associated with genetic diseases or infiltrative or destructive disease of endocrine organs (testis, hypothalamus-pituitary)
- •Patients on oral hypoglycemic agents treatment or in the 3 months preceding the start of the study
- •Patients on lipid-lowering drug therapy or in the 3 months preceding the start of the study
- •Known or suspected hypersensitivity to the drug or drug class in the study;
- •Patients with serious medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study;
- •Use of systemic experimental drugs in the last 3 months before inclusion in the study.
- •Patients unable to follow the procedures of the Protocol.
研究者
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