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Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04579406
Acronym
DMPACE
Enrollment
200
Registered
2020-10-08
Start date
2020-10-15
Completion date
2023-06-30
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy, Type 2 Diabetes

Keywords

Diabetes mellitus, adverse cardiovascular events, nerve degeneration, peripheral sensory nerves

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.

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.

Interventions

PROCEDUREnon-cardiac surgery

All the patients are undergoing non-cardiac surgery.

Sponsors

Second Hospital of Shanxi Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
adverse cardiovascular eventsPerioperative periodAll the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account.

Secondary

MeasureTime frameDescription
NPY, CGRP, SP and TRPV1Perioperative periodThe difference in the serum levels of NPY, CGRP, SP and TRPV1

Countries

China

Contacts

Primary ContactZheng Guo, M.B., Ph.D.
guozheng713@yahoo.com+863513365790

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026