Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Association of Changes in NPY, CGRP, SP and TRPV1 With Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

Conditions
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Type 2 Diabetes, Neuropathy

Intervention / Treatment
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* Procedure: non-cardiac surgery


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-diabetic group<br>The non-diabetic patients undergoing non-cardiac surgery. | Procedure: non-cardiac surgery<br>* All the patients are undergoing non-cardiac surgery.<br>|
| Diabetic group<br>The diabetic patients without peripheral neuropathy undergoing non-cardiac surgery. | Procedure: non-cardiac surgery<br>* All the patients are undergoing non-cardiac surgery.<br>|
| Diabetic neuropathic group<br>The diabetic patients with peripheral neuropathy undergoing non-cardiac surgery. | Procedure: non-cardiac surgery<br>* All the patients are undergoing non-cardiac surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse cardiovascular events | All the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account. | Perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPY, CGRP, SP and TRPV1 | The difference in the serum levels of NPY, CGRP, SP and TRPV1 | Perioperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, adverse cardiovascular events, nerve degeneration, peripheral sensory nerves