Clinical trial NCT05068895: Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes
Official title: Assessment of Metabolic Profiles of Lower Extremity Arterial Disease in Patiens Withe Type 2 Diabetes Via LC-MS-based Nontargeted Metabolomic Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Angiopathies
Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Lower extremity artery disease
Metabolic Profiles
Metabolic biomarkers
Metabolomics
iquid chromatography-mass spectrometry
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Metabolic profiles of lower extremity artery disease
timeFrame: 4 months
Secondary outcomes:
measure: Potential biomarker analysis for discrimination
timeFrame: 4 months
measure: Pathway analysis of differential metabolites
timeFrame: 4 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
state: Chongqing
Study officials:
affiliation: The third hospital affiliated to the Third Military Medical University
name: Zhencheng Yan, MD
role: STUDY_DIRECTOR
References:
citation: 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.