Diabetic cardiac autonomic neuropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Date of birth range: January 1, 1955, to December 31, 1975 (i.e., age at enrollment: 50–70 years). 2.Meeting the diagnostic criteria for diabetes mellitus.
Exclusion criteria
Exclusion criteria: 1.Presence of conditions unsuitable for cardiac autonomic reflex tests (CARTs). 2.Acute kidney injury within the past 6 months; OR non-diabetes-related primary kidney diseases affecting renal function (e.g., obstructive renal failure, nephritis syndrome, non-diabetic nephrotic syndrome, etc.); OR post-nephrectomy/kidney transplant status. 3.Myocardial infarction, stroke, or transient ischemic attack (TIA) within the past 6 months; History of coronary revascularization or hospitalization for heart failure within the past 6 months; Any cardiac arrhythmia (excluding occasional premature beats) or implanted pacemaker/defibrillator; Persistent heart failure (NYHA Class III or IV); Post-cardiac valve replacement or heart transplantation. 4.Decompensated liver cirrhosis or liver failure; Unstable critical illness requiring emergency intervention OR intensive care unit (ICU) admission within the past 6 months; History of malignancy with significant impact on life expectancy (e.g., metastatic/terminal cancer); Severe psychiatric disorders OR physical disability significantly impairing function. 5.Any other condition(s) deemed by the investigator to compromise participant safety or study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A decline in eGFR >= 40%; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality;Cardiac composite outcome (nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization);Renal composite outcome:>= 40% decline in eGFR,Sustained eGFR <15 mL/min/1.73m^2,Chronic kidney replacement therapy,Renal death.;KDIGO kidney risk classification progression;UACR upward slope;eGFR decline slope; | — |
Countries
China
Contacts
Shenzhen People's Hospital