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

September 25, 2021 updated by: Zhiming Zhu

Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes Via LC-MS-based Nontargeted Metabolomic Approach

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • The third hospital affiliated to the Third Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
Pathway analysis of differential metabolites
Time Frame: 4 months
Conducting pathway analysis for the significant metabolites identified by using MetaboAnalyst.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhiming Zhu

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

October 9, 2021

Study Completion (Anticipated)

October 15, 2021

Study Registration Dates

First Submitted

September 25, 2021

First Submitted That Met QC Criteria

September 25, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 25, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP of LEAD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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