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

NCT ID: NCT05068895

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Angiopathies Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group1

Volunteers with normal glucose tolerance.

liquid chromatography-mass spectrometry

Intervention Type OTHER

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.

Group2

type 2 diabetic patients without microvascular (retinopathy, nephropathy or neuropathy) or macrovascular (coronary, cerebrovascular or lower extremity arterial disease) complications.

liquid chromatography-mass spectrometry

Intervention Type OTHER

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.

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).

liquid chromatography-mass spectrometry

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Metabolomics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhiming Zhu

OTHER

Sponsor Role lead

Responsible Party

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Zhiming Zhu

Director of the department of Hypertension & Endocrinology, Daping Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhencheng Yan, MD

Role: STUDY_DIRECTOR

The third hospital affiliated to the Third Military Medical University

Locations

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The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhencheng Yan, MD

Role: primary

86-023-68757882

References

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You M, Liu Y, Wang B, Li L, Zhang H, He H, Zhou Q, Cao T, Wang L, Zhao Z, Zhu Z, Gao P, Yan Z. Asprosin induces vascular endothelial-to-mesenchymal transition in diabetic lower extremity peripheral artery disease. Cardiovasc Diabetol. 2022 Feb 15;21(1):25. doi: 10.1186/s12933-022-01457-0.

Reference Type DERIVED
PMID: 35168605 (View on PubMed)

Other Identifiers

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MP of LEAD

Identifier Type: -

Identifier Source: org_study_id

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