Hyperlipidemia, Ursodeoxycholic Acid, Statin Therapy, Glucose Intolerance
Conditions
Brief summary
The purpose of this clinical trial is to understand whether the drug Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in participants with hyperlipidemia who are taking statins. It will also assess the safety of UDCA. The primary questions it aims to answer are: * Will UDCA reduce the incidence of glucose intolerance in participants taking oral statins? * Will the use of UDCA decrease other adverse events in patients taking oral statins? Participants will: * Take Atorvastatin combined with UDCA or a placebo daily for 6 months * Have follow-up visits on day 40, day 110, and day 180 Have their examination indicators recorded.
Interventions
UDCA together with statin in eligible participants
DRUGPlacebo
placebo together with statin in ASCVD patients
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-75 years old. * LDL-C≥3.4mmol/l (130 mg/dL). * Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol). * Voluntarily sign informed consent.
Exclusion criteria
* Previous diagnosis of diabetes or prediabetes. * Past or current use of hypoglycemic drugs. * Oral administration of statin lipid-lowering drugs within three months before enrollment. * Combined oral drug quantity ≥3. * History of ASCVD (previous myocardial infarction, ACS, stroke or TIA within 1 year, symptomatic peripheral vascular disease). * Active liver disease (defined as elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) \>2 × upper limit of normal (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. * Difficult to control hypertension: defined as systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite antihypertensive therapy prior to randomization. * Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method * New York Heart Association (NYHA) Class IV heart failure or a known left ventricular ejection fraction \< 25% * A clinically significant and drug- or ablation-resistant arrhythmia within 3 months prior to randomization * 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 * Scheduled for surgery within 6 months * Pregnant, breastfeeding, or trying to become pregnant during the study or within 6 months of study completion * Subjects with alcohol or other drug addiction * Secondary hypercholesterolemia, such as hypothyroidism or nephrotic syndrome * A history of allergic reaction to any study drug or its excipients or similar chemical classes of drugs * A family history of homozygous familial hypercholesterolemia * Participants currently enrolled in another clinical trial, or who cannot adhere to 6-month follow-up * Any condition that the investigator considers unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months after randomization | Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of fasting blood glucose | 6 months after randomization | The concentration of fasting blood glucose was measured and serum was extracted for laboratory testing. |
| Concentration of fasting islets | 6 months after randomization | The concentration of fasting islets was measured and serum was extracted for laboratory testing. we use the level of physiological parameter to describe the concentration of fasting islets. |
| Concentration of blood lipid | 6 months after randomization | The concentration of blood lipid was measured and serum was extracted for laboratory testing.we use the level of physiological parameter to describe the concentration of blood lipid, including the level of triglycerides,the level of low-density lipoprotein, the level of high-density lipoprotein, the level of total cholesterol ,the level of Lipoprotein(a). |
| Body composition analysis Fat mass | 6 months after randomization | The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g.Fat mass |
| Body composition analysis Muscle mass | 6 months after randomization | The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g. Muscle mass. |
Countries
China
Contacts
Primary ContactYue Yu
Backup ContactYue Wu, Professor
Outcome results
None listed