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临床试验/NCT05752591
NCT05752591已完成不适用

Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus

Istituto Auxologico Italiano2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年5月25日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Bonomi

MD, Professor

Istituto Auxologico Italiano

研究点 (2)

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