Clinical trial NCT04572802: Changes of Serum Orphanin FQ in Patients With Coronary Heart Disease in Different Courses of Diabetes Mellitus
Official title: Study on the Changes of Serum Orphanin FQ in Patients With Diabetes Mellitus and Coronary Heart Disease in Different Courses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Keywords: Type 2 diabetes
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes complicated with coronary heart disease

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Gensini score
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Second of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: Second Hospital of Shanxi Medical University
name: zheng guo, doctor
role: PRINCIPAL_INVESTIGATOR
References: