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临床试验/NCT04451616
NCT04451616Unknown不适用

Assessment of Progranulin and Chemokine-like Protein TAFA-5 (FAM19A5) Blood Levels in Adults With Metabolic Syndrome

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年7月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
FAM19A5 Protein

研究概览

简要总结

The main objective of the study is to assess the serum levels of progranulin and FAM19A5 protein in adults with metabolic syndrome.

详细描述

The study is planned to be conducted on 40 adults with metabolic syndrome. As a control, it is planned to recruit 40 adults without metabolic syndrome. From all participants fasting venous blood samples, urine samples and hair samples will be collected. Next, serum progranulin and serum FAM19A5 protein concentrations will be determined in both groups. Also, serum concentration of leptin, vascular endothelial growth factor (VEGF), insulin, neopterin, adropin and selected cytokines, adipokines, myokines and chemokines, total cholesterol, low-density lipoproteins, high-density lipoproteins, triglycerides and glucose will be determined. Serum, hair and urine mineral content will be determined. In whole blood genetic analyses will be performed in order to detect and examine progranulin and FAM19A5 genes, and genes associated with the development of metabolic syndrome and genes associated with the body's mineral metabolism. Also, body composition analysis, blood pressure measurement, pulse measurement, blood oxygen saturation measurement and nutritional interview will be performed.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written and informed consent of the participant to participate in the study;
  • age 18-99;
  • meeting at least three of the following five metabolic syndrome criteria:
  • waist circumference ≥80 cm in women and ≥94 cm in men;
  • serum triglycerides> 150 mg / dl (1.7 mmol / l) or treatment of hypertriglyceridemia;
  • HDL serum concentration <50 mg / dl (1.3 mmol / l) - in women and <40 mg / dl (1.0 mmol / l) - in men or treatment of this lipid disorder;
  • systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg, or treatment of previously diagnosed hypertension;
  • fasting plasma glucose ≥100 mg / dl (5.6 mmol / l) or pharmacological treatment of type 2 diabetes.

排除标准

  • secondary form obesity,
  • substitution of progranulin or / and FAM19A5 protein,
  • weight reduction above 5% of baseline body weight in the last 3 months preceding recruitment,
  • liposuction and / or other fat reduction treatments,
  • pacemaker, cardioverter / defibrillator,
  • condition after stroke,
  • Alzheimer's disease,
  • fronto-temporal dementia,
  • occurrence of other neurodegenerative diseases,
  • occurrence of significant neurological disorders,
  • occurrence of inflammatory autoimmune diseases,
  • lysosomal storage diseases,
  • clinically significant abnormal liver, kidney or thyroid function;
  • acute or clinically significant inflammatory process in the respiratory, digestive, genitourinary tracts,
  • connective tissue diseases or arthritis;
  • active cancer,
  • addiction to alcohol or drugs;
  • pregnancy or childbirth during recruitment or 3 months before recruitment;
  • current lactation or lactation within 3 months before recruitment;
  • and / or any other condition which, according to researchers, would cause that participation would not be in the patient's best interest or could limit the credibility of the study

结局指标

主要结局

FAM19A5 Protein

时间窗: Measured at baseline

Concentration of FAM19A5 protein in serum

Progranulin

时间窗: Measured at baseline

Concentration of progranulin in serum

次要结局

  • FAM19A5 protein genes(Measured at baseline)
  • Adropin(Measured at baseline)
  • Zinc level in hair(Measured at baseline)
  • Leptin(Measured at baseline)
  • Insulin(Measured at baseline)
  • Iron level in hair(Measured at baseline)
  • Copper level in hair(Measured at baseline)
  • Zinc level in serum(Measured at baseline)
  • Body mass (BM)(Measured at baseline)
  • Systolic blood pressure(Measured at baseline)
  • Pulse(Measured at baseline)
  • Blood oxygen level(Measured at baseline)
  • High density lipoprotein (HDL)(Measured at baseline)
  • Neopterin(Measured at baseline)
  • Iron level in serum(Measured at baseline)
  • Zinc level in urine(Measured at baseline)
  • Copper level in urine(Measured at baseline)
  • Muscle mass content(Measured at baseline)
  • Diastolic blood pressure(Measured at baseline)
  • Total cholesterol (TCH)(Measured at baseline)
  • Triglycerides(Measured at baseline)
  • Glucose(Measured at baseline)
  • Progranulin genes(Measured at baseline)
  • Vascular endothelial growth factor (VGEF)(Measured at baseline)
  • Waist circumference (WC)(Measured at baseline)
  • Low density lipoprotein (LDL)(Measured at baseline)
  • Neck circumference(Measured at baseline)
  • Total water content(Measured at baseline)
  • Copper level in serum(Measured at baseline)
  • Iron level in urine(Measured at baseline)
  • Hip circumference(Measured at baseline)
  • Body fat content(Measured at baseline)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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