Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

Recruiting

• Conditions: Type 2 Diabetes; Neuropathy
• Interventions: Procedure: non-cardiac surgery

• Registration Number: NCT04579406
• Lead Sponsor: Second Hospital of Shanxi Medical University

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.

Study Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Study Start: 2020-10-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic group	non-cardiac surgery	The diabetic patients without peripheral neuropathy undergoing non-cardiac surgery.
Diabetic neuropathic group	non-cardiac surgery	The diabetic patients with peripheral neuropathy undergoing non-cardiac surgery.
non-diabetic group	non-cardiac surgery	The non-diabetic patients undergoing non-cardiac surgery.

Primary Outcome Measures

Name	Time	Method
adverse cardiovascular events	Perioperative period	All the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account.

Secondary Outcome Measures

Name	Time	Method
NPY, CGRP, SP and TRPV1	Perioperative period	The difference in the serum levels of NPY, CGRP, SP and TRPV1

Trial Locations

Locations (1)

Zheng Guo; 🇨🇳 Taiyuan, Shanxi, China