None
Conditions
Interventions
ursodeoxycholic acid group:The group was given ursodeoxycholic acid tablets 500mg oral treatment
placebo group:The group was given placebo tablets 500mg oral treatment
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 40-75 years old. 2.LDL-C=4.1mmol/l (160 mg/dL). 3. Glycosylated hemoglobin < 6.0% (39 mmol/mol). 4. Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of diabetes or prediabetes. 2. Past or current use of hypoglycemic drugs. 3. Previous lipid-lowering treatment with lipid-lowering drugs or other means (such as traditional Chinese medicine or omega-3 fatty acids). 4. Taking glucocorticoid drugs or using birth control drugs. 5. Combined oral drug quantity =3. 6. History of ASCVD (previous myocardial infarction, ACS, stroke or TIA within 1 year, symptomatic peripheral vascular disease). 7. Active liver disease (defined as elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN) or total bilirubin >2 × ULN from any existing known liver infectious, neoplastic, or metabolic pathologic cause or unknown cause at the time of screening), Severe hepatic insufficiency and biliary obstruction. 8. Difficult to control hypertension: defined as systolic blood pressure =180mmHg or diastolic blood pressure =110mmHg despite antihypertensive therapy prior to randomization. 9. Estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method; 10. New York Heart Association (NYHA) Class IV heart failure or a known left ventricular ejection fraction < 25%; 11. A clinically significant and drug- or ablation-resistant arrhythmia within 3 months prior to randomization; 12. An acute or severe systemic infection, or any of the following diseases: hematological disorders, autoimmune disorders, malignant tumors, psychiatric patients, or other serious or unstable conditions that could impact study health status; 13. Scheduled for surgery within 6 months; 14. Pregnant, breastfeeding, or trying to become pregnant during the study or within 6 months of study completion; 15. Subjects with alcohol or other drug addiction; 16. Secondary hypercholesterolemia, such as hypothyroidism or nephrotic syndrome; 17. A history of allergic reaction to any study drug or its excipients or similar chemical classes of drugs; 18. A family history of homozygous familial hypercholesterolemia; 19. Participants currently enrolled in another clinical trial, who have withdrawn within the past month, or who cannot adhere to 6-month follow-up; 20. Any condition that the investigator considers unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin; | — |
Countries
China
Contacts
Public ContactYuan Zuyi
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed