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临床试验/NCT05759637
NCT05759637招募中不适用

Type 2 Diabetes, Obesity and Cortisol Excess

Istituto Auxologico Italiano5 个研究点 分布在 1 个国家目标入组 3,200 人开始时间: 2022年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,200
试验地点
5
主要终点
Hidden Hypercortisolism prevalence in a sample of T2D patients

研究概览

简要总结

The present observational cross-sectional study is aimed to assess: the hidden hypercortisolism (HidHyCo) prevalence in a sample of Type 2 diabetes (T2D) patients and the clinical characteristics more frequently associated with the HidHyCo presence and the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the HidHyCo presence.

详细描述

Mild and asymptomatic hypercortisolism has been described to be associated with increased prevalence of chronic complications of cortisol excess, such as osteoporosis, hypertension, type 2 diabetes (T2D) and obesity and with increased mortality. In patients with osteoporosis, hypertension, T2D or obesity, this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo), until its presence is suspected on the basis of particular characteristics of the underlying diseases. The HidHyCo prevalence in the general population is estimated to be 0.2-2%, but it has been suggested to be even higher (up to 10%) in some specific populations as for example in patients T2D. Data regarding the prevalence of HidHyCo in obese populations are limited, Therefore, the issue of which diabetic or obese patient has to be screened for HidHyCo has recently become a widely debated topic. Therefore, the aims of the present study protocol are to assess: i) the HidHyCo prevalence in a sample of T2D patients and the clinical characteristics more frequently associated with the HidHyCo presence; ii) the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the HidHyCo presence.

All T2D and obese-without T2D patients between 18 and 75 years of age, consecutively referred to the out-patient clinics for Diabetes and Obesity of our center will be assessed for possible inclusion. At the enrolment in all patients anthropometric e biochemical variables will be recorded. At the enrolment we will evaluate cortisol levels after dexamethasone suppression test (F-1mgDST) in all T2D and obese-without T2D patients, who have been included in the study and who have given the informed consent to participate in the study. In all subjects with F-1mgDST >1.8 μg/dL, cortisol levels after two-day low dose (2 mg/day) dexamethasone suppression test (F-2mgx2dDST) will be performed. Patients with F-2mgx2dDST above >1.8 μg/dL will be considered affected with possible HidHyCo and will be studied following the available guidelines for the diagnosis of hypercortisolism.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with T2D and Obesity

排除标准

  • pregnancy/breast feeding,
  • sleep apnea,
  • prepuberal onset of hypertension, hormonal hypersecreting adrenal mass,
  • symptoms of hypercortisolism;
  • already known secondary hypertension;
  • conditions associated with increased hypothalamic-pituitary-adrenal (HPA) axis activity, -severe autoimmune/rheumatologic and hematologic diseases, alcoholism, kidney disease (glomerular filtration rate <60)
  • drugs influencing the HPA axis activity. For inclusion in Group 2 the presence of T2D will be an exclusion criteria

结局指标

主要结局

Hidden Hypercortisolism prevalence in a sample of T2D patients

时间窗: 24 months

prevalence of patients with F-1mgDST\>1.8 mcg/dl

Hidden Hypercortisolism prevalence in a sample of Obese patients

时间窗: 24 months

prevalence of patients with F-1mgDST\>1.8 mcg/dl

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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