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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Neuropathy
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Zheng Guo, M.B., Ph.D.; Phone Number: +863513365790; Email: guozheng713@yahoo.com

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • Zheng Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic patients with and without peripheral sensory neuropathy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-diabetic group; The non-diabetic patients undergoing non-cardiac surgery.	Procedure: non-cardiac surgery; All the patients are undergoing non-cardiac surgery.
Diabetic group; The diabetic patients without peripheral neuropathy undergoing non-cardiac surgery.	Procedure: non-cardiac surgery; All the patients are undergoing non-cardiac surgery.
Diabetic neuropathic group; The diabetic patients with peripheral neuropathy undergoing non-cardiac surgery.	Procedure: non-cardiac surgery; All the patients are undergoing non-cardiac surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Hospital of Shanxi Medical University
• Investigators: Study Director: Zheng Guo, M.B., Ph.D., Second Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes mellitus; adverse cardiovascular events; nerve degeneration; peripheral sensory nerves
• Other Study ID Numbers: ScondShanxiMU-1646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Yes, if possible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No