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

Zhiming Zhu

Status: Unknown

Conditions: Diabetic Angiopathies; Diabetes Mellitus, Type 2

Treatments: Other: liquid chromatography-mass spectrometry

Study type: Observational

Funder types: Other

Identifiers

NCT05068895

MP of LEAD

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

74 participants in 3 patient groups

Group1

Description:

Volunteers with normal glucose tolerance.

Treatment:

Other: liquid chromatography-mass spectrometry

Group2

Description:

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

Treatment:

Other: liquid chromatography-mass spectrometry

Group3

Description:

type 2 diabetic patients with lower extremity artery disease diagnosed through the measurement of ABI (the ratio of ankle-to-brachial systolic blood pressure).

Treatment:

Other: liquid chromatography-mass spectrometry