Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

NCT ID: NCT04579406

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-diabetic group

The non-diabetic patients undergoing non-cardiac surgery.

non-cardiac surgery

Intervention Type PROCEDURE

All the patients are undergoing non-cardiac surgery.

Diabetic group

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

non-cardiac surgery

Intervention Type PROCEDURE

All the patients are undergoing non-cardiac surgery.

Diabetic neuropathic group

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

non-cardiac surgery

Intervention Type PROCEDURE

All the patients are undergoing non-cardiac surgery.

Interventions

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non-cardiac surgery

All the patients are undergoing non-cardiac surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Hospital of Shanxi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zheng Guo

Professor and chairman of the Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zheng Guo, M.B., Ph.D.

Role: STUDY_DIRECTOR

Second Hospital of Shanxi Medical University

Locations

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Zheng Guo

Taiyuan, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zheng Guo, M.B., Ph.D.

Role: CONTACT

+863513365790

Facility Contacts

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Zheng Guo, MB,PhD

Role: primary

+863513365790

Weijun Liang, MSc

Role: backup

+863513365790

Other Identifiers

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ScondShanxiMU-1646

Identifier Type: -

Identifier Source: org_study_id

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