diabetes
Conditions
Interventions
experimental group: Henagliflozin
control group:Standard treatment (excluding SGLT2 inhibitors and GLP-1 receptor agonists)
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with type 2 diabetes, aged 30-75 years; 2. Diagnosed with type 2 diabetes according to the 1999 World Health Organization (WHO) criteria; 3. Diagnosis of diabetic cardiac autonomic neuropathy (Ewing score >=2) or early cardiac autonomic neuropathy (2Score >Ewing score >=1 score);Can cooperate with the completion of cardiac autonomic nervous function evaluation; 4. The diabetes treatment plan is stable within three months; No SGLT2i and GLP-1 receptor agonists were used 3 months before enrollment; 5. If eGFR>30ml/min, Estimated glomerular filtration (eGFR) was calculated using the CKD-EPI formula; 6. Sign the research informed consent;
Exclusion criteria
Exclusion criteria: 1. Impaired liver function [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times normalUpper limit]; 2.Uncontrolled unstable or stable angina pectoris, ECG or serum blood indicates myocardial ischemia, and a heart attack occurs within 6 months Myocardial infarction, stroke, severe cardiac insufficiency (NYHA grade ?-?) and other cardiovascular events; 3.Abnormal thyroid function; 4. Chronic obstructive pulmonary disease; 5. Proliferative retinopathy; 6.Poorly controlled hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure > 100mmHg); 7. Non-diabetic CAN, such as Parkinson's disease, multiple system atrophy, amyotrophic lateral sclerosis, autoimmune diseases (such as Sjogren's syndrome) that may cause CAN; 8. Install a pacemaker; 9. Known frequent (> 6 beats /min) or persistent arrhythmias; 10. Have used SGLT2i or GLP-1 RA drugs within 3 months; 11. LIn the state of fever, infection, dehydration, hypoglycemia or severe hyperglycemia [fasting Lblood glucose (FPG) > 13.9mmol/L] Or hemoglobin a1c (HbA1c) > 12%]; 12. Binge drinking (long-term alcohol consumption > 5 years, equivalent to alcohol levels of >=40g/d for males and >=20 g/d for females, or large amounts within 2 weeks Alcohol consumption history, equivalent alcohol content >80 g/d); 13. If you are pregnant or have a pregnancy plan within the next 1 year; 14. Allergic to SGLT2i drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRV,Heart Rate Variability;Cardiac autonomic function CARTs score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood sugar-related indicators;Lipid profile (total cholesterol, triglycerides, HDL, LDL);Cardiac ultrasound index (Left Ventricular Ejection Fraction (LVEF), Ventricular septal thickness, and left ventricular posterior wall thickness); | — |
Countries
China
Contacts
Public ContactFu Xiaoying
Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)
Outcome results
None listed