Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- pioglitazone effect on testosterone level
研究概览
简要总结
To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.
详细描述
Several clinical studies demonstrated that pioglitazone not only improves insulin sensitivity but also decreases plasma androgen concentrations (DHEAS and androstenedione) in women with polycystic ovary syndrome (PCOS) . However the reduction in the androgen levels in PCOS is whether secondary to increase in the insulin sensitivity or due to direct effect of thiazolidinediones on steroidogenesis is not known.So far, two human studies have been conducted regarding the effects of rosiglitazone (a thiazolidinedione group of drug) on testosterone level, one in healthy individuals and another was in patients of type 2 diabetes with hypogonadism . But these studies gave equivocal results as the study population were different. Hence we plan to study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HbA1c level of 7.5% or less on stable dosages of sulphonylurea (glimepiride 1-6mg/day) and metformin (1-2g/day) for at least six weeks and BMI of 20-30 kg/m2.
排除标准
- •hepatic impairment, coronary artery disease and or heart failure, renal failure, those who requires insulin therapy or HbA1c >7.5%, presence of macular edema and serum albumin <3gm/dL.
结局指标
主要结局
pioglitazone effect on testosterone level
时间窗: three months
次要结局
未报告次要终点