Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes Via LC-MS-based Nontargeted Metabolomic Approach
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Metabolic profiles of lower extremity artery disease
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- 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
- •type 1 diabetes
- •patients with mental abnormality who are uncooperative with this study
- •pregnant or lactating women
- •refuse to sign informed consent
Outcomes
Primary Outcomes
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 Outcomes
- Pathway analysis of differential metabolites(4 months)
- Potential biomarker analysis for discrimination(4 months)
Investigators
Zhiming Zhu
Director of the department of Hypertension & Endocrinology, Daping Hospital
Third Military Medical University