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

Sponsor
Zhiming Zhu (Other)
Overall Status
Recruiting
CT.gov ID
NCT05068895
Collaborator
(none)
74
Enrollment
1
Location
4.5
Anticipated Duration (Months)
16.6
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Other: liquid chromatography-mass spectrometry

Study Design

Study Type:
Observational
Anticipated 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 :
Jun 1, 2021
Anticipated Primary Completion Date :
Oct 9, 2021
Anticipated Study Completion Date :
Oct 15, 2021

Arms and Interventions

ArmIntervention/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 Names:
  • 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 Names:
  • 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 Names:
  • Metabolomics
  • Outcome Measures

    Primary Outcome Measures

    1. Metabolic profiles of lower extremity artery disease [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 [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 [4 months]

      Conducting pathway analysis for the significant metabolites identified by using MetaboAnalyst.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1The third hospital affiliated to the Third Military Medical UniversityChongqingChongqingChina400042

    Sponsors and Collaborators

    • Zhiming Zhu

    Investigators

    • Study Director: Zhencheng Yan, MD, The third hospital affiliated to the Third Military Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Oct 6, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhiming Zhu, Director of the department of Hypertension & Endocrinology, Daping Hospital, Third Military Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021