Perioperative Adverse Cardiovascular Event in Type-2 Diab... | NCT04579406

Studies
Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

NCT04579406

Sponsor

Second Hospital of Shanxi Medical University

Status

Unknown status

Last Update Posted

Apr 12, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Type 2 Diabetes
Neuropathy

Interventions

non-cardiac surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2020Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Oct 1, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zheng Guo, Professor and chairman of the Department of Anesthesiology, Second Hospital of Shanxi Medical UniversityPrincipal Investigator

Lead Sponsor

Second Hospital of Shanxi Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
non-diabetic group	The non-diabetic patients undergoing non-cardiac surgery.	Procedure: non-cardiac surgery
Diabetic group	The diabetic patients without peripheral neuropathy undergoing non-cardiac surgery.	Procedure: non-cardiac surgery
Diabetic neuropathic group	The diabetic patients with peripheral neuropathy undergoing non-cardiac surgery.	Procedure: non-cardiac surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-cardiac surgery	Procedure	All the patients are undergoing non-cardiac surgery.	Diabetic group Diabetic neuropathic group non-diabetic group

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
NPY, CGRP, SP and TRPV1	The difference in the serum levels of NPY, CGRP, SP and TRPV1	Perioperative period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Type 2 diabetic patients with and without peripheral sensory neuropathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zheng Guo, M.B., Ph.D.	Contact	+863513365790		guozheng713@yahoo.com

Overall Officials

Name	Affiliation	Role
Zheng Guo, M.B., Ph.D.	Second Hospital of Shanxi Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zheng Guo	Recruiting	Taiyuan	Shanxi	030001	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Yes, if possible.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus
D009410	Nerve Degeneration

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided