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

• Conditions: Diabetic Angiopathies; Diabetes Mellitus, Type 2
• Interventions: Other: liquid chromatography-mass spectrometry

• Registration Number: NCT05068895
• Lead Sponsor: Zhiming Zhu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-25
• Study First Submitted QC: 2021-09-25
• Last Update Submitted: 2021-09-25
• Study First Posted: 2021-10-06
• Last Update Posted: 2021-10-06
• Primary Completion: 2021-10-09
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group2	liquid chromatography-mass spectrometry	type 2 diabetic patients without microvascular (retinopathy, nephropathy or neuropathy) or macrovascular (coronary, cerebrovascular or lower extremity arterial disease) complications.
Group1	liquid chromatography-mass spectrometry	Volunteers with normal glucose tolerance.
Group3	liquid chromatography-mass spectrometry	type 2 diabetic patients with lower extremity artery disease diagnosed through the measurement of ABI (the ratio of ankle-to-brachial systolic blood pressure).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pathway analysis of differential metabolites	4 months	Conducting pathway analysis for the significant metabolites identified by using MetaboAnalyst.
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.

Trial Locations

Locations (1)

The third hospital affiliated to the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China