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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes Via LC-MS-based Nontargeted Metabolomic Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068895
• Other study ID #: MP of LEAD
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: September 2021
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: October 15, 2021
• Est. primary completion date: October 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Angiopathies

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	The third hospital affiliated to the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhiming Zhu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Potential biomarker analysis for discrimination	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.	4 months
Secondary	Pathway analysis of differential metabolites	Conducting pathway analysis for the significant metabolites identified by using MetaboAnalyst.	4 months