Clinical trial NCT04579406: Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
Official title: Association of Changes in NPY, CGRP, SP and TRPV1 With Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Neuropathy
Keywords: Diabetes mellitus
adverse cardiovascular events
nerve degeneration
peripheral sensory nerves
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients with and without peripheral sensory neuropathy

Brief summary: The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery.

Detailed description: The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery. Diabetes mellitus and peripheral sensory nerve degeneration will be diagnosed via clinical evaluation. Serum levels of constituent neuropeptides, including neuropeptide Y (NPY), calcitonin and substance P (SP) and calcitonin gene related peptide (CGRP), and transient receptor potential vanilloid 1 (TRPV1), a molecular nociceptor in peripheral sensory nerves will be quantitatively evaluated. The clinical and the biochemical consequence will be compared between the cohorts of diabetic and non-diabetic patients. The differences and the correlations will be analyzed. The results of the study may reveal whether or not the perioperative adverse cardiovascular events in diabetic patients are correlated with degeneration of peripheral sensory nerves and the alterations in the neuropeptides and TRPV1 are potentially applicable for evaluation of the risk of cardiovascular events in perioperative period in diabetic patients.

Eligibility criteria: Inclusion Criteria:

* The main discharge diagnosis is T2DM；
* Age \> 18 years old;
* No acute complications of diabetes

Exclusion Criteria:

* T1DM patients;
* EGFR \< 60 ml/min/1.73 m or proteinuria (or both);
* Patients with history of acute cardiovascular events;
* Familial hypercholesterolemia or other hereditary lipid metabolism diseases;
* anti-HIV patients;
* Patients with serious mental health problems;
* Patients receiving drugs that can lead to dyslipidemia, such as antipsychotics, corticosteroids, or immunosuppressants;
* Patients with systemic inflammatory diseases, such as systemic lupus erythematosus;
* Patient are quitting smoking and severe obesity (BMI\>40)

Primary outcomes:
measure: adverse cardiovascular events
timeFrame: Perioperative period
Secondary outcomes:
measure: NPY, CGRP, SP and TRPV1
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Zheng Guo
state: Shanxi
Study officials:
affiliation: Second Hospital of Shanxi Medical University
name: Zheng Guo, M.B., Ph.D.
role: STUDY_DIRECTOR
References: