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Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT05068895
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

Brief Summary:
The prevalence of lower extremity arterial disease (LEAD) in patients with diabetes increases significantly and are characterized with obvious arteriosclerosis that are caused by multiple metabolic disorders. Metabolomics measures the metabolites in biological fluids or tissues that generated under certain conditions via rapidly evolving high-throughput technology. Herein, the investigators designed the study to characterize the serum metabolic profiles of LEAD patients and identify metabolic biomarkers using metabolomics. The serum of volunteers, type 2 diabetes mellitus(T2DM) patients with or without LEAD were collected and analyzed using liquid chromatography-mass spectrometry(LC-MS) coupled with a series of multivariate statistical analyses.

Condition or disease Intervention/treatment
Diabetic Angiopathies Diabetes Mellitus, Type 2 Other: liquid chromatography-mass spectrometry

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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes Via LC-MS-based Nontargeted Metabolomic Approach
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : October 9, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group1
Volunteers with normal glucose tolerance.
Other: liquid chromatography-mass spectrometry
Metabolomics is a rapidly evolving high-throughput technology that allows the measurement of the entire complement of metabolites generated by biochemical reactions under certain conditions in biological fluids or tissues. This technology has been used extensively to identify biomarkers in various cancers, nervous system diseases, cardiovascular diseases, pituitary diseases, and other diseases. The identification of biomarkers can be clinically useful for a more accurate diagnosis, prognosis, and treatment choice as well as disease monitoring. Among mass spectrometry (MS) methods, liquid chromatography-mass spectrometry (LC-MS) has been recognized as a robust metabolomics tool and has been widely applied in metabolite identification and quantification due to its high sensitivity, peak resolution, and repro- ducibility.
Other Name: Metabolomics

Group2
type 2 diabetic patients without microvascular (retinopathy, nephropathy or neuropathy) or macrovascular (coronary, cerebrovascular or lower extremity arterial disease) complications.
Other: liquid chromatography-mass spectrometry
Metabolomics is a rapidly evolving high-throughput technology that allows the measurement of the entire complement of metabolites generated by biochemical reactions under certain conditions in biological fluids or tissues. This technology has been used extensively to identify biomarkers in various cancers, nervous system diseases, cardiovascular diseases, pituitary diseases, and other diseases. The identification of biomarkers can be clinically useful for a more accurate diagnosis, prognosis, and treatment choice as well as disease monitoring. Among mass spectrometry (MS) methods, liquid chromatography-mass spectrometry (LC-MS) has been recognized as a robust metabolomics tool and has been widely applied in metabolite identification and quantification due to its high sensitivity, peak resolution, and repro- ducibility.
Other Name: Metabolomics

Group3
type 2 diabetic patients with lower extremity artery disease diagnosed through the measurement of ABI (the ratio of ankle-to-brachial systolic blood pressure).
Other: liquid chromatography-mass spectrometry
Metabolomics is a rapidly evolving high-throughput technology that allows the measurement of the entire complement of metabolites generated by biochemical reactions under certain conditions in biological fluids or tissues. This technology has been used extensively to identify biomarkers in various cancers, nervous system diseases, cardiovascular diseases, pituitary diseases, and other diseases. The identification of biomarkers can be clinically useful for a more accurate diagnosis, prognosis, and treatment choice as well as disease monitoring. Among mass spectrometry (MS) methods, liquid chromatography-mass spectrometry (LC-MS) has been recognized as a robust metabolomics tool and has been widely applied in metabolite identification and quantification due to its high sensitivity, peak resolution, and repro- ducibility.
Other Name: Metabolomics




Primary Outcome Measures :
  1. Metabolic profiles of lower extremity artery disease [ Time Frame: 4 months ]
    LC-MS analysis will be performed using a Q ExactiveTM HF-X liqiud chromatograph system coupled with a Thermo ScientificTM OrbitrapTM mass spectrometer according to a previously published procedure to detect the peak, identify the metabolites and perform the PCA and OPLS-DA analyses to better visualize the subtle similarities and differences among the complex datasets.


Secondary Outcome Measures :
  1. Potential biomarker analysis for discrimination [ Time Frame: 4 months ]
    Screening for potential biomarkers will be performed according to the VIP value (VIP > 1.0) and significance test (P < 0.05) from the OPLS-DA model.

  2. Pathway analysis of differential metabolites [ Time Frame: 4 months ]
    Conducting pathway analysis for the significant metabolites identified by using MetaboAnalyst.


Biospecimen Retention:   Samples Without DNA
serum


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We collected serum samples and clinical data of 74 volunteers and patients with T2DM who hospitalized in our department from June 2021 to September 2021.
Criteria

Inclusion Criteria:

  • age ranges from 18 to 100 years old
  • Signed informed consent and agreed to participate in this study
  • The diagnosis of T2DM is based on standard criteria recommended by WHO since 1999
  • The diagnosis of T2DM patient with LEAD is based on standard criteria recommended by Chinese guideline on prevention and management of diabetic foot (2019 edition)(II).

Exclusion Criteria:

  • younger than 18 years old or older than 100 years old
  • acute infection during the preceding 3 months
  • drugs or alcohol addicts
  • cancer
  • type 1 diabetes
  • patients with mental abnormality who are uncooperative with this study
  • pregnant or lactating women
  • refuse to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068895


Locations
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China, Chongqing
The third hospital affiliated to the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Zhencheng Yan, MD    86-023-68757882    zhenchengyan@sina.com   
Sponsors and Collaborators
Zhiming Zhu
Investigators
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Study Director: Zhencheng Yan, MD The third hospital affiliated to the Third Military Medical University
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Responsible Party: Zhiming Zhu, Director of the department of Hypertension & Endocrinology, Daping Hospital, Third Military Medical University
ClinicalTrials.gov Identifier: NCT05068895    
Other Study ID Numbers: MP of LEAD
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhiming Zhu, Third Military Medical University:
Diabetes Mellitus, Type 2
Lower extremity artery disease
Metabolic Profiles
Metabolic biomarkers
Metabolomics
iquid chromatography-mass spectrometry
Additional relevant MeSH terms:
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Diabetic Angiopathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications