Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490926
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-07-01
Brief Title:
NMR Based Metabolomic Study of Serum Biomarkers in Patients With Parkinsons Disease and Atypical Parkinsonian Syndrome
Sponsor:
Fujian Medical University Union Hospital
Organization:
Fujian Medical University Union Hospital
Study Overview
Official Title:
NMR Based Metabolomic Study of Serum Biomarkers in Patients With Parkinsons Disease and Atypical Parkinsonian Syndrome
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At present the diagnosis of Parkinsons diseasePD mainly relies on clinical symptoms and is easily confused with atypical Parkinsonian syndromeAPS in the early stages There is an urgent need for reliable biomarkers This project aims to use metabolomics technology based on proton nuclear magnetic resonance spectroscopy to study the metabolomic characteristics of patients with PD and APS and preliminarily screen for possible diagnostic biomarkers of PD and APS
Detailed Description:
Parkinsons diseasePD is the second largest neurodegenerative disease with a prevalence rate of 17 among the population aged 65 and above in China Approximately 3 million people suffer from this disease As the disease progresses the quality of life of patients is seriously affected causing a significant burden on both families and society At present treatment methods cannot reverse or prevent the progression of the disease which is related to difficulties in early diagnosis and missed opportunities for drug intervention as well as the lack of developed drugs with disease modifying effects Research has found that when patients experience clinical motor symptoms such as tremors it means that at least 50 of dopaminergic neurons are lost and the dopamine neurotransmitter content in the striatum is reduced by more than 80 At this time patients have missed the opportunity for early intervention Therefore early diagnosis and intervention of PD have a significant impact on the prognosis of patients The etiology and pathogenesis of PD are complex and have not yet been fully elucidated In recent years research progress in epidemiology pathophysiology genomics proteomics and other fields has provided important clues for revealing the etiology and pathogenesis of PD At present it is believed that PD may be influenced by genes gut microbiota diet lifestyle habits and different environmental factors Research on its pathogenesis mainly focuses on oxidative stress neurotoxicity central nervous system inflammation and immune response mitochondrial energy metabolism disorders and other aspects
Atypical Parkinsonian syndromeAPS includes progressive supranuclear palsy PSP and multiple system atrophy MSA etc PD and MSA belong to a group of synucleopathies characterized by fibrous aggregation of alpha synuclein in the cytoplasm of selected neuronal and glial cell populations PSP is a tau protein disease associated with pathological aggregation of microtubule associated tau proteins The absence of dopaminergic nerves is a common feature of all Parkinsonian syndromes therefore PD and APS share some common clinical neuropathological and genetic features In the early stages of the disease due to the overlap of motor and non motor symptoms The clinical differentiation between PD and APS is difficult Therefore searching for biological markers for PD and MSA The clinical diagnosis and differential diagnosis of PSP are of great significance for the research of disease diagnosis and disease modification therapy
In the past 20 years The study of biomarkers for PD and APS has always been a hot topic in various fields Currently PD biomarkers are divided into three categories clinical biomarkers functional neuroimaging biomarkers and biochemical biomarkers Clinical biomarkers are divided into non motor symptoms and motor symptom evaluations but there are fluctuations and overlaps in clinical symptom manifestations which affect the correct identification and evaluation of diseases and have a certain misdiagnosis rate Functional neuroimaging includes technologies such as brain PET metabolic imaging transcranial ultrasound imaging and magnetic resonance imaging which are easy to operate but expensive and have low specificity With the mature application of platforms such as proteomics genomics and metabolomics more and more biochemical markers have emerged Some scholars believe that the study of biomarkers must be closely related to the etiology and pathogenesis Therefore the study of biochemical markers can better reveal the etiology and pathogenesis becoming an important direction of current research In recent years extensive research has been conducted on the pathogenesis of PD through the misfolding aggregation and intercellular transmission of alpha synuclein The study suggests that the toxicity of alpha synuclein is influenced by its physical and physiological status genetic mutations neuroinflammation and lipid metabolism The interaction between them may contribute to the pathogenesis of PD The latest preclinical evidence suggests that the bidirectional communication between gut microbiota dysbiosis and the brain nervous system plays an important role in the metabolism and pathology of PD patients The metabolome can be considered as the ultimate result of the interaction between gene expression protein expression and environment Metabolomics is considered the omics science that best studies the phenotype and genotype of organisms as well as the relationship between phenotype and environment Compared with other omics techniques metabolomics has become an ideal source for the discovery of biomarkers
Another important role of metabolomics is to measure a spectrum of metabolic changes caused by disease drug and toxin exposure known as metabolic fingerprints which can be used to characterize specific categories health or disease control or drug treatment etc and determine the overall characteristics that distinguish categories or groups Therefore it can be used for diagnosing disease status prognosis and monitoring treatment At present metabolomics is widely used in molecular and individualized medicine as well as research based on single-cell and epidemiological populations metabolic phenotype and metabolomics association studies Metabolomics techniques are increasingly being applied in the study of central nervous system diseases such as Alzheimers disease depression etc Currently PD is considered a multifactorial disease with strong clinical heterogeneity Some foreign research reports PD patients experience disturbances in metabolic pathways such as lipid energy fatty acid and amino acid metabolismThe reason for clinical heterogeneity in PD patients may be due to the different pathological and physiological mechanisms among different subtypes of PD Studies have found that the levels of important molecules ie niacin cadherin glucuronic acid are correlated with the severity of the phenotype and there may be potential pathological and physiological connections between gut microbiotametabolites and the subtypes of PD However these results still need to be validated in more research At present there is relatively little metabolomic research on PD patients in China especially in the early stage of PD and the metabolomic characteristics of different APS have not been reported The metabolomics analysis technique to be used in this study is proton nuclear magnetic resonance technology which is a major metabolomics analysis technique Compared with other analytical techniques NMR has the following advantages 1 Simple pre-treatment of biological samples 2 Multiple biomarkers can be observed simultaneously providing complete biological information for disease diagnosis and pathological analysis 3 Non destructive testing 4 Can provide both qualitative and semi quantitative information on specific substances in the sample simultaneously 5 Can achieve high-throughput detection In metabolomics research the most widely used method is 1D proton nuclear magnetic resonance spectroscopy with hydrogen nuclei as the detection objectThe hydrogen containing compounds in the sample all exhibit nuclear magnetic resonance NMR effects so 1D proton NMR spectroscopy can collect proton signals from each compound in the sample without bias providing a fingerprint of metabolites
NMR can analyze various types of biological samples and cerebrospinal fluid is the preferred choice for PD in vivo studies However obtaining cerebrospinal fluid from patients carries associated risks which reduces the value of cerebrospinal fluid as a routine diagnostic tool The readily available biological fluids serum urine provide a safer option Metabolites can cross the blood-brain barrier therefore serum metabolites are increasingly being used to study potential biomarkers of diseases
Atypical Parkinsonian syndromeAPS includes progressive supranuclear palsy PSP and multiple system atrophy MSA etc PD and MSA belong to a group of synucleopathies characterized by fibrous aggregation of alpha synuclein in the cytoplasm of selected neuronal and glial cell populations PSP is a tau protein disease associated with pathological aggregation of microtubule associated tau proteins The absence of dopaminergic nerves is a common feature of all Parkinsonian syndromes therefore PD and APS share some common clinical neuropathological and genetic features In the early stages of the disease due to the overlap of motor and non motor symptoms The clinical differentiation between PD and APS is difficult Therefore searching for biological markers for PD and MSA The clinical diagnosis and differential diagnosis of PSP are of great significance for the research of disease diagnosis and disease modification therapy
In the past 20 years The study of biomarkers for PD and APS has always been a hot topic in various fields Currently PD biomarkers are divided into three categories clinical biomarkers functional neuroimaging biomarkers and biochemical biomarkers Clinical biomarkers are divided into non motor symptoms and motor symptom evaluations but there are fluctuations and overlaps in clinical symptom manifestations which affect the correct identification and evaluation of diseases and have a certain misdiagnosis rate Functional neuroimaging includes technologies such as brain PET metabolic imaging transcranial ultrasound imaging and magnetic resonance imaging which are easy to operate but expensive and have low specificity With the mature application of platforms such as proteomics genomics and metabolomics more and more biochemical markers have emerged Some scholars believe that the study of biomarkers must be closely related to the etiology and pathogenesis Therefore the study of biochemical markers can better reveal the etiology and pathogenesis becoming an important direction of current research In recent years extensive research has been conducted on the pathogenesis of PD through the misfolding aggregation and intercellular transmission of alpha synuclein The study suggests that the toxicity of alpha synuclein is influenced by its physical and physiological status genetic mutations neuroinflammation and lipid metabolism The interaction between them may contribute to the pathogenesis of PD The latest preclinical evidence suggests that the bidirectional communication between gut microbiota dysbiosis and the brain nervous system plays an important role in the metabolism and pathology of PD patients The metabolome can be considered as the ultimate result of the interaction between gene expression protein expression and environment Metabolomics is considered the omics science that best studies the phenotype and genotype of organisms as well as the relationship between phenotype and environment Compared with other omics techniques metabolomics has become an ideal source for the discovery of biomarkers
Another important role of metabolomics is to measure a spectrum of metabolic changes caused by disease drug and toxin exposure known as metabolic fingerprints which can be used to characterize specific categories health or disease control or drug treatment etc and determine the overall characteristics that distinguish categories or groups Therefore it can be used for diagnosing disease status prognosis and monitoring treatment At present metabolomics is widely used in molecular and individualized medicine as well as research based on single-cell and epidemiological populations metabolic phenotype and metabolomics association studies Metabolomics techniques are increasingly being applied in the study of central nervous system diseases such as Alzheimers disease depression etc Currently PD is considered a multifactorial disease with strong clinical heterogeneity Some foreign research reports PD patients experience disturbances in metabolic pathways such as lipid energy fatty acid and amino acid metabolismThe reason for clinical heterogeneity in PD patients may be due to the different pathological and physiological mechanisms among different subtypes of PD Studies have found that the levels of important molecules ie niacin cadherin glucuronic acid are correlated with the severity of the phenotype and there may be potential pathological and physiological connections between gut microbiotametabolites and the subtypes of PD However these results still need to be validated in more research At present there is relatively little metabolomic research on PD patients in China especially in the early stage of PD and the metabolomic characteristics of different APS have not been reported The metabolomics analysis technique to be used in this study is proton nuclear magnetic resonance technology which is a major metabolomics analysis technique Compared with other analytical techniques NMR has the following advantages 1 Simple pre-treatment of biological samples 2 Multiple biomarkers can be observed simultaneously providing complete biological information for disease diagnosis and pathological analysis 3 Non destructive testing 4 Can provide both qualitative and semi quantitative information on specific substances in the sample simultaneously 5 Can achieve high-throughput detection In metabolomics research the most widely used method is 1D proton nuclear magnetic resonance spectroscopy with hydrogen nuclei as the detection objectThe hydrogen containing compounds in the sample all exhibit nuclear magnetic resonance NMR effects so 1D proton NMR spectroscopy can collect proton signals from each compound in the sample without bias providing a fingerprint of metabolites
NMR can analyze various types of biological samples and cerebrospinal fluid is the preferred choice for PD in vivo studies However obtaining cerebrospinal fluid from patients carries associated risks which reduces the value of cerebrospinal fluid as a routine diagnostic tool The readily available biological fluids serum urine provide a safer option Metabolites can cross the blood-brain barrier therefore serum metabolites are increasingly being used to study potential biomarkers of diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None