Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes
1 other identifier
observational
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 25, 2021
CompletedFirst Posted
Study publicly available on registry
October 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2021
CompletedOctober 6, 2021
September 1, 2021
4 months
September 25, 2021
September 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic profiles of lower extremity artery disease
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 Outcomes (2)
Potential biomarker analysis for discrimination
4 months
Pathway analysis of differential metabolites
4 months
Study Arms (3)
Group1
Volunteers with normal glucose tolerance.
Group2
type 2 diabetic patients without microvascular (retinopathy, nephropathy or neuropathy) or macrovascular (coronary, cerebrovascular or lower extremity arterial disease) complications.
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).
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhiming Zhulead
Study Sites (1)
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Related Publications (1)
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.
PMID: 35168605DERIVED
Biospecimen
serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhencheng Yan, MD
The third hospital affiliated to the Third Military Medical University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the department of Hypertension & Endocrinology, Daping Hospital
Study Record Dates
First Submitted
September 25, 2021
First Posted
October 6, 2021
Study Start
June 1, 2021
Primary Completion
October 9, 2021
Study Completion
October 15, 2021
Last Updated
October 6, 2021
Record last verified: 2021-09