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
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedApril 12, 2023
April 1, 2023
2.7 years
October 1, 2020
April 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adverse cardiovascular events
All the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account.
Perioperative period
Secondary Outcomes (1)
NPY, CGRP, SP and TRPV1
Perioperative period
Study Arms (3)
non-diabetic group
The non-diabetic patients undergoing non-cardiac surgery.
Diabetic group
The diabetic patients without peripheral neuropathy undergoing non-cardiac surgery.
Diabetic neuropathic group
The diabetic patients with peripheral neuropathy undergoing non-cardiac surgery.
Interventions
All the patients are undergoing non-cardiac surgery.
Eligibility Criteria
Type 2 diabetic patients with and without peripheral sensory neuropathy
You may qualify if:
- The main discharge diagnosis is T2DM；
- Age \> 18 years old;
- No acute complications of diabetes
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zheng Guo
Taiyuan, Shanxi, 030001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zheng Guo, M.B., Ph.D.
Second Hospital of Shanxi Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and chairman of the Department of Anesthesiology
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 8, 2020
Study Start
October 15, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
April 12, 2023
Record last verified: 2023-04