Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients (DMPACE)

Shanxi Medical University

Status: Enrolling

Conditions: Type 2 Diabetes; Neuropathy

Treatments: Procedure: non-cardiac surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04579406

ScondShanxiMU-1646

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

200 participants in 3 patient groups

non-diabetic group

Description:

The non-diabetic patients undergoing non-cardiac surgery.

Treatment:

Procedure: non-cardiac surgery

Diabetic group

Description:

The diabetic patients without peripheral neuropathy undergoing non-cardiac surgery.

Treatment:

Procedure: non-cardiac surgery

Diabetic neuropathic group

Description:

The diabetic patients with peripheral neuropathy undergoing non-cardiac surgery.

Treatment:

Procedure: non-cardiac surgery