Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Prevalence of Hypogonadism
研究概览
简要总结
Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Even if hypogonadism is associated to a worse metabolic profile and cardiovascular risk, it is discussed whether and when to treat this potentially reversible form associated to diabetes. In fact, the pathogenic mechanism of this condition in diabetic patients is not fully understood, and its clinical correlates, including the prevalence of other possible associated hypothalamic-pituitary axes dysfunctioning, questioned. The aim of the present study is to assess with an observational, cross sectional study on a large series of type 2 diabetic patients, enrolled consecutively: all the suspected etiologies of this complication in one single evaluation (both acquired and genetic congenital predisposition), its clinical correlates and the real prevalence of the disease using the lastly validated criteria for late onset hypogonadotropic hypogonadism.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 years old
- •proved diagnosis of T2DM
排除标准
- •patients affected with known hypothalamic-pituitary diseases at the enrollment.
- •patients affected with severe systemic diseases, fever, chronic inflammatory disorders with PCR > 10 mg/dL
- •malnutrition with BMI <17 Kg/m2
- •use of glucocorticoids at the enrollment
- •poor understanding of spoken and written Italian
- •patients affected with known primary diseases of the testes at the enrollment
结局指标
主要结局
Prevalence of Hypogonadism
时间窗: baseline
LH, FSH, Testosterone, Estradiol
Genetic predisposition
时间窗: baseline
NGS analysis based on the analysis of a customized gene-panel with all known Congenital Hypogonadotropic Hypogonadism genes
次要结局
未报告次要终点
研究者
Marco Bonomi
MD, Professor
Istituto Auxologico Italiano
