Dyslipidemia
Conditions
Interventions
XZK group:XZK 1200mg/d, 24 weeks
Atorvastatin group:atorvastatin 20mg/d, 24 weeks
Sponsors
Ruyang Rural Health Centre
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent provided; 2. Aged 40 years and over; 3. Diagnosed Prediabetes, meeting one of the following conditions: (1) Impaired fasting glucose (IFG): 5.6 mmol/L = 3.4mmol/L and = 4.1 mmol/L and < 5.7 mmol/L, and TG <= 5.6 mmol/L; 5. Completed one-week Patient diary, recorded at least 5 days in a week.
Exclusion criteria
Exclusion criteria: 1. Patient with proven or documented atherosclerotic cardiovascular disease (ASCVD) including Acute coronary syndrome (ACS), history of myocardial infarction (MI), stable or unstable angina pectoris, coronary or other revascularization, ischemic stroke, transient ischemic attack and peripheral vascular disease (PAD),etc.; 2.Diagnosed diabetes according to 2021 the American Diabetes Association (ADA) Standards of Medical Care in Diabetes: (1) FPG >= 126 mg/dL (7.0 mmol/L); (2) 2-h PG >= 200 mg/dL (11.1 mmol/L) during OGTT; (3) A1C >= 6.5% (48 mmol/mol); (4) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose >= 200 mg/dL (11.1 mmol/L); 3. Patients with any lipid lowering drugs in the previous 3 months, including but not limited to statins, bile acid sequestrants, cholesterol absorption inhibitors, PCSK9 inhibitors, nicotinic acid, fibric acid derivatives, fibrates, other traditional Chinese medicine and n-3 fatty acids; 4. Patients with any antidiabetic drugs; 5. Contraindications to XZK or Atorvastatin: (1) Allergic to XZK or Atorvastatin; (2) Pregnancy or breastfeeding; 6. Uncontrolled hypertension (systolic blood pressure >= 180 mm Hg and/ or diastolic blood pressure >= 110 mm Hg) at screening; 7. Active liver disease or hepatic dysfunction, including continuously elevated liver transaminase due to unknown causes. Abnormal liver function test at baseline (ALT or AST > 3 x ULN); 8. Known renal dysfunction or elevated serum creatinine levels at baseline (with an eGFR <= 60 mL/min/1.73 m2); 9. Other endocrine diseases that might influence the levels of lipid or lipoprotein, such as hypothyroidism; 10. Patient has participated in clinical trials of other drugs in the past three months; 11. Previous statin treatment causes creatine kinase (CK) increased 10 times, or myalgia myopathy (muscle pain or muscle weakness, accompanied by Creatine phosphokinase (CK) exceeds 10 times the ULN); 12. Estimated life expectancy < 6 months at the time of enrollment; 13. Abuse of alcohol, or history of alcohol abuse; 14. Close affiliation with the investigators, e.g., a close relative for the investigator, dependent person (e.g., employee or student of the investigators).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting blood glucose;2 h PPG;HOMA-IR;LDL-C;non HDL-C; | — |
Countries
China
Contacts
Public ContactMa Changsheng
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed