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

Study on the Changes of Serum Orphanin FQ in Patients With Diabetes Mellitus and Coronary Heart Disease in Different Courses

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

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Procedure: Coronary angiography

Detailed Description

Methods: A retrospective case-control study was conducted. The control group was a patient who underwent coronary angiography at the same time and was definitely diagnosed as coronary heart disease but not diabetes. The study group was coronary heart disease complicated with diabetes, which was divided into group A (≤5 years), group B (5-10 years) and group C (10-20 years) according to the course of diabetes. (1) Review the electronic medical records and record the general information of the selected patients: age, sex, history of hypertension, history of myocardial infarction, family history of coronary heart disease, smoking history, chronic kidney disease; ② laboratory findings: HbA1C (glycosylated hemoglobin), SBP (systolic blood pressure), DBP (diastolic blood pressure), total cholesterol, HDL, LDL, triglyceride, BMI, creatinine and glomerular passing rate (EGFR); ③ Drug use: oral hypoglycemic agents, insulin, aspirin, statins, hypertension drugs, ACEI or ARB, β-blockers, CCB and diuretics. (ii) Taking coronary angiography as the gold standard, the grading index of severity of coronary heart disease was made, and the severity of coronary heart disease was evaluated by Gensini score.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Second of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes complicated with coronary heart disease

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Coronary angiography was performed in patients with coronary heart disease complicated with type 2 diabetes mellitus
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; Coronary angiography was performed in patients with coronary heart disease complicated with type 2 diabetes mellitus
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; Coronary angiography was performed in patients with coronary heart disease complicated with type 2 diabetes mellitus
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; Coronary angiography was performed in patients with coronary heart disease complicated with type 2 diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Hospital of Shanxi Medical University
• Investigators: Principal Investigator: zheng guo, doctor, Second Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 diabetes
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: hanyi20200802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All IPD that underlie results in a publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No