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临床试验/NCT03937284
NCT03937284已完成不适用

Lipoprotein Lipidic Composition, Lipopolysaccharide Binding Protein, and Bacterial Endotoxin Exposure in Parkinson's Disease: A Pilot Study

University of Milan1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年5月3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
45
试验地点
1
主要终点
LPS

研究概览

简要总结

Patients with Parkinson's disease (PD) present an impaired intestinal permeability with consequent lipopolysaccharide (LPS) translocation in the systemic circulation. Plasmatic lipoproteins play a key role in the detoxification of LPS.

The investigators aim to study the relationships between lipoprotein chemical composition and plasma LPS circulation in PD.

详细描述

Bacterial lipopolysaccharides are able to produce neuroinflammation and dopaminergic receptors degeneration. In addition, they may produce an accumulation of α-synuclein in the area of the substantia Nigra. Recent studies have shown that α-synuclein aggregates may be present also in gastrointestinal neurons of patients with PD. This last finding led to the hypothesis that the intestine might be an early site of PD disease in response to an environmental toxin or pathogen. Forsyth et al. have discovered an impaired intestinal permeability in subjects with recently diagnosed PD, and they found positive correlations between this factor, exposure to LPS and alpha-synuclein accumulation in gastrointestinal neurons. Plasma lipoproteins play a key role in the detoxification of bacterial endotoxins. Lipoprotein chemical composition is related to their detoxing properties. To the best of investigator knowledge, the relationships between lipoprotein chemical composition and LPS in PD have not yet been investigated. Therefore, the aims of this study are: I) to evaluate the chemical composition of VLDL, LDL and HDL in subjects with PD compared to a control group; 2) to analyze the activity of plasma lipid transfer proteins and LPS plasma levels in the same groups of subjects; III) finally, to investigate the correlations between the analyzed parameters.

Subjects and method Twenty patients with PD and twenty healthy controls were recruited for the study. Fasting blood samples were taken for routine laboratory analysis and for the separation of EDTA plasma. Plasma samples stored at -80°C until were used for lipoprotein isolation and analysis and for the measurement of lipid transfer protein and LPS levels.

研究设计

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

入排标准

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

入选标准

  • Diagnosis of Parkinson disease in agreement with UK Brain Bank
  • Farmacological treatment with L-Dopa and/or dopaminergic agonist or diagnosis de novo
  • BMI 18.5 - 29.9 kg/m^2
  • Informed consent signature
  • Exclusion criteria:
  • Presence of type 1 and type 2 diabetes mellitus
  • Presence of major chronic diseases of the digestive tract.
  • Pregnancy in progress
  • Subjects subjected to antihypertensive therapies or statins or with drugs that can change metabolic status and insulin sensitivity (e.g. chronic oral steroid therapy)
  • Subjects affected by endocrine pathologies (e.g. Cushing disease, uncontrolled thyroid disease)
  • Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl
  • Presence of chronic liver disease or ALT and AST levels exceeding two standard deviations from normal levels
  • Presence of malignant disease
  • Alcohol or drug abuse
  • Major psychiatric disorders
  • Subjects dedicated to intense and agonistic physical activity.
  • Control group
  • Inclusion criteria
  • Absence of major disease
  • BMI 18.5 - 29.9 kg/m^2
  • Informed consent signature

排除标准

  • Presence of type 1 and type 2 diabetes mellitus
  • Presence of major chronic diseases of the digestive tract.
  • Pregnancy in progress
  • Subjects subjected to antihypertensive therapies or statins or with drugs that can change metabolic status and insulin sensitivity (e.g. chronic oral steroid therapy)
  • Subjects affected by endocrine pathologies (e.g. Cushing disease, uncontrolled thyroid disease)
  • Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl
  • Presence of chronic liver disease or ALT and AST levels exceeding two standard deviations from normal levels
  • Presence of malignant disease
  • Alcohol or drug abuse
  • Major psychiatric disorders
  • Subjects dedicated to intense and agonistic physical activity.

结局指标

主要结局

LPS

时间窗: through study completion an average of 1 year

LPS plasma levels (EU/L)

Lipoprotein chemical composition

时间窗: through study completion an average of 1 year

Cholesterol (mg/dL); HDL-cholesterol (mg/dL); triglycerides (mg/dL); phospholipids (mg/dL), apoproteins (mg/dL) of VLDL, LDL and HDL

次要结局

  • Plasma lipid transfer proteins(through study completion an average of 1 year)

研究者

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

roberta cazzola

Principal Investigator

University of Milan

研究点 (1)

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