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临床试验/NCT04133441
NCT04133441已完成不适用

25-Hydroxyvitamin D Levels Are Negatively Associated With Platelets Number in a Cohort of Overweight and Obese Subjects

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 341 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
341
试验地点
1
主要终点
Vitamin D

研究概览

简要总结

This study was aimed to investigate the associations between platelet number and 25(OH)D serum concentration in apparently healthy but overweight/obese subjects.

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. We 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. To lead the statistical analysis, all sample was clusterized into three different groups according to the diagnostic condition of deficiency (<10 ng/mL), insufficiency (<20 ng/mL) and sufficiency (≥20 ng/mL) of vitamin D. We labelled each cluster as group 1, group 2 and group 3.

研究设计

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

入排标准

性别
All
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

Vitamin D

时间窗: At baseline

Vitamin D (ng/mL) concentration in serum

Platelets

时间窗: At baseline

Platelets (cells/mm3) number in serum

次要结局

  • Total cholesterol(At baseline)
  • Insulin(At baseline)
  • Thyroid hormones (FT3, FT4)(At baseline)
  • HDL cholesterol(At baseline)
  • eGFR (estimated glomerular filtration rate)(At baseline)
  • Creatinin(At baseline)
  • BMI(At baseline)
  • TSH(At baseline)
  • Weight(At baseline)
  • LDL cholesterol(At baseline)
  • Height(At 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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