Cardiac autonomic neuropathy (CAN) in patients with diabetes mellitus
Conditions
Interventions
Hospitalized patients who meet the inclusion and exclusion criteria.:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years. 2. Meet the diagnostic criteria for diabetes mellitus as defined by the World Health Organization (WHO) or the American Diabetes Association (ADA); 3. Conscious and deemed capable of understanding and completing the cardiac autonomic function tests.
Exclusion criteria
Exclusion criteria: 1. Patients with acute diabetic complications (e.g., ketoacidosis, hyperosmolar state); 2. Consumption of caffeine, alcohol, or other stimulant-containing substances within 24 hours prior to or during the test procedures; 3. Engagement in vigorous physical activity during the test period that may interfere with the final results; 4. Presence of acute stress conditions secondary to events such as cerebral infarction, cerebral hemorrhage, myocardial infarction, active infection, or recent major surgery; 5. Documented severe cardiac disease (including but not limited to acute or old myocardial infarction, heart failure, cardiomyopathy, angina pectoris, congenital heart disease, ischemic heart disease), or implantation of a permanent pacemaker or cardioverter-defibrillator, as confirmed by medical history, physical examination, electrocardiogram, chest X-ray, and laboratory investigations; 6. Diagnosis of anemia, or severe hepatic, renal, or other systemic diseases; 7. Presence of proliferative diabetic retinopathy or retinal hemorrhage, as identified by fundus examination; 8. Use of medications known to affect heart rate variability (HRV) — such as beta-blockers, propafenone, or digitalis glycosides — within the past month; 9. History of psychiatric disorders (e.g., epilepsy, neurosis), recent use of psychotropic medications (e.g., antidepressants, anxiolytics), or poor compliance; 10. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of cardiac autonomic neuropathy (CAN) in the diabetic patient cohort; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity grading of cardiac autonomic neuropathy in diabetic patients;Abnormality rates of various cardiac autonomic function tests;Odds ratios of risk factors associated with CAN;Prevalence of CAN in key subgroups (stratified by sex, disease duration, glycemic control, etc.); | — |
Countries
China
Contacts
Public ContactKong Feijuan
Shanghai General Hospital
Outcome results
None listed