The Correlation Between Testosterone and Cortisol Level and Inflammatory Markers Levels in Type 2 Diabetic Men.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Cortisol level
研究概览
简要总结
Many type 2 diabetic men have low serum testosterone levels. Our aim in this trial is to check if there is a correlation between serum or hair testosteron levels and serum or hair cortisol levels in type 2 diabetic men. We'll also examine whether there is a correlation between serum and hair testosterone levels and cortisol levels and serum inflammatory markers.
If such correlation will be found- then it is possible that excess cortisol or an abnormal inflammatory status- may cause the low testosterone levels that seen in type 2 diabetic men.
详细描述
Eligible participants are type 2 diabetic men who visit our clinic, as part of their routine medical surveillance, and other 10 healthy volunteers (men) as a control group.
All the participants will sign an informed consent form. The study will include 30 type 2 diabetic men, (40-55 years old) and 10 healthily volunteers (same age group).
In addition to routine blood test of blood count, kidney function and liver enzymes will be taken blood samples of total testosterone serum levels, total cortisol serum levels and serum inflammation markers levels, and also a sample of head-hair for cortisol and testosterone levels (1 cm of occipital hair weighing 50 mg).
Optional: from patients who will agree to visit the clinic after 8 hours-fast will be also taken one additional blood sample of fasting glucose, insulin and C-peptide levels, in order to estimate their insulin resistance status, and it's possible correlation to the other measures.
From the 10 healthy volunteers In addition will be taken blood and hair samples of the above parameters, as a control.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •men age 40-55
- •type 2 diabetic
排除标准
- •septic disease
结局指标
主要结局
Cortisol level
时间窗: 24 months
single blood and hair sample will be drawn to measure cortisol levels (mcg/dl)
C-reactive protein levels
时间窗: 24 months
single blood sample will be drawn to measure c-reactive protein levels (mcg/dl)
Testosterone level
时间窗: 24 months
single blood and hair sample will be drawn to measure Testosterone levels (nmol/L)
Anti Tumor Necrosis Factor alpha
时间窗: 24 months
single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml)
次要结局
未报告次要终点