Changes of Serum Orphanin FQ in Patients With Coronary Heart Disease in Different Courses of Diabetes Mellitus

NCT04572802 | Completed DMC

• 1 other identifier: hanyi20200802
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the severity of diabetic patients with coronary heart disease and the change of serum orphanin FQ content in different diabetic courses

Conditions

Type2 Diabetes

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Gensini score

  Gensini score was used to evaluate the severity of coronary artery occlusion, and then compared with the population of type 2 diabetes complicated with coronary heart disease

  1 week

Study Arms (4)

control group

Coronary heart disease population: after coronary angiography, Gensini score was used to evaluate the severity of coronary artery occlusion, and then compared with the population of type 2 diabetes complicated with coronary heart disease

Procedure: Coronary angiography

experimental group (course of disease <5 years)

Type 2 diabetes complicated with coronary heart disease (course of disease 5-10 years).Retrospective examination of patients' data, recording patients' laboratory tests and drug use, taking blood to measure orphanin, and evaluating the severity of coronary artery occlusion with Gensini score.

Procedure: Coronary angiography

experimental group(course of disease 5-10 years)

Type 2 diabetes complicated with coronary heart disease (course of disease 5-10 years).

Procedure: Coronary angiography

experimental group(course of disease10-20 years)

Type 2 diabetes complicated with coronary heart disease (course of disease 10 -20years).Finally, the data were obtained to evaluate the relationship between the course of diabetes and the severity of coronary heart disease, as well as the relationship between the course of diabetes and OFQ in patients' blood.

Procedure: Coronary angiography

Interventions

Coronary angiography PROCEDURE

Coronary angiography was performed in patients with coronary heart disease complicated with type 2 diabetes mellitus

control group; experimental group (course of disease <5 years); experimental group(course of disease 5-10 years); experimental group(course of disease10-20 years)

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes complicated with coronary heart disease

You may qualify if:

• The main discharge diagnosis is T2DM；;
• Age \> 18 years old;
• No acute complications of diabetes;
• The previous diagnosis was coronary heart disease

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; Pet-name ruby is quitting smoking and severe obesity (BMI\>40).

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum orphanin FQ,Glycosylated hemoglobin

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• zheng guo, doctor

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigation

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 1, 2020
• Study Start: October 10, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 30, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)