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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572802
• Other study ID #: hanyi20200802
• Status: Completed
• Start date: October 10, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2022
• Source: Second Hospital of Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia
• Type2 Diabetes

Intervention

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

Locations

Country	Name	City	State
China	Second of Shanxi Medical University	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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