Type 2 diabetes
Conditions
Interventions
experimental group:henagliflozin
control group:placebo
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this clinical study and sign the informed consent form; 2. Meet the 1999 World Health Organization (WHO) diagnostic criteria for type 2 diabetes mellitus; 3. No gender limit, age 35-70 years old; 4. Patients who did not receive antihyperglycemic drugs during the screening period of =12 weeks and whose glycosylated hemoglobin (HbA1c) was 7.0-9.5% were enrolled; 5. Fasting C-peptide =1.0 ng/ml; 6. Fasting blood glucose < 13.3mmol/L; 7. Body mass index (BMI)=22.0kg/m2;
Exclusion criteria
Exclusion criteria: 1. Hyperglycemia due to other diseases; 2. Type 1 diabetes mellitus; 3. Severe diabetic complications, such as diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome, or lactic acidosis; 4. Blood pressure still =160/100mmHg on 3 consecutive different days after the use of 3 antihypertensive drugs; 5. Allergic to SGLT2i; 6. Patients who had received other SGLT2i therapy within 6 months; 7. Severe liver and kidney function impairment (eGFR <60 mL/min/1.73m2; Levels of aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase above three times the upper limit of normal);any uncontrolled endocrine disease other than type 2 diabetes; 8. Patients with myocardial infarction, unstable angina pectoris, cardiac surgery, or revascularization (coronary artery bypass grafting/percutaneous coronary angioplasty), or severe heart failure, New York Heart Association (NYHA) grade III or greater, in the 6 months before the trial;cerebrovascular accident or serious infection; a history of immune dysfunction or cancer; 9. Current continuous systemic corticosteroids or immunosuppressive agents; 10. Pregnancy/planned pregnancy/lactation; 11. History of repeated genitourinary infection, or genitourinary infection within 3 months; 12. Participated in other research projects within the last 3 months or two or more projects within the last 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DNA methylation clock;Telomere length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin-like growth factor 1 and its binding protein;Islet function (HOMA-IR, HOMA-ß);Inflammatory indicators (interleukin-6, interleukin-8, tumor necrosis factor-a, C-reactive protein);ß-hydroxybutyric acid;Body composition indicators (lean body mass, body fat and percentage body fat); | — |
Countries
China
Contacts
Public ContactXu Jixiong
17 Yongwai Zhengjie, Donghu District, Nanchang City, Jiangxi Province, China
Outcome results
None listed