Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

Type 2 Diabetes Clinical Trial

— DMPACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579406
• Other study ID #: ScondShanxiMU-1646
• Status: Recruiting
• Start date: October 15, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Second Hospital of Shanxi Medical University
• Contact: Zheng Guo, M.B., Ph.D.
• Phone: +863513365790
• Email: guozheng713[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuropathy
• Type 2 Diabetes

Intervention

Procedure:
• non-cardiac surgery
All the patients are undergoing non-cardiac surgery.

Locations

Country	Name	City	State
China	Zheng Guo	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse cardiovascular events	All the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account.	Perioperative period
Secondary	NPY, CGRP, SP and TRPV1	The difference in the serum levels of NPY, CGRP, SP and TRPV1	Perioperative period