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临床试验/NCT04354285
NCT04354285已完成不适用

24-hour Urinary Aldosterone And Endocrine System In Obesity

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
Thyroid hormones (FT3, FT4)

研究概览

简要总结

The study was aimed at investigating the relationship between hormone parameters and urinary aldosterone levels in 24h within a cohort of overweight and obesity.

详细描述

Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP) and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

接受健康志愿者

入选标准

  • Overweight or obesity (BMI> 25 Kg/m2)

排除标准

  • Any kind of drug
  • Hypertension
  • Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
  • Chronic inflammatory diseases
  • Renal failure
  • Liver failure
  • Angina pectoris
  • Myocardial infarction and heart failure
  • Genetic heart diseases
  • Thrombocytopenias

结局指标

主要结局

Thyroid hormones (FT3, FT4)

时间窗: Baseline

FT3 (pg/mL), FT4 (pg/mL) concentration in serum

TSH

时间窗: Baseline

TSH (mU/L) concentration in serum

Urinary Aldosterone

时间窗: Baseline

24-h Urine Aldosterone (mg/24 h)

Prolactin

时间窗: Baseline

Prolactin (ng/ml) concentration in serum

Insulin

时间窗: Baseline

Insulin (mIU/L) concentration in serum

Parathyroid Hormone

时间窗: Baseline

PTH (pg/mL) concentration in serum

次要结局

  • Total cholesterol(Baseline)
  • HDL cholesterol(Baseline)
  • LDL cholesterol(Baseline)
  • BMI(Baseline)
  • Height(Baseline)
  • Weight(Baseline)
  • Vitamin D(Baseline)

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluigi Giannelli

Clinical Professor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

研究点 (1)

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