Ursodeoxycholic acid helps prevent glucose intolerance in statin users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in individuals with hyperlipidemia who are undergoing treatment with statins. Participants will take Atorvastatin along with either UDCA or a placebo daily for six months, with follow-up visits to monitor their health indicators. The study aims to determine if UDCA can reduce the incidence of glucose intolerance and other adverse effects associated with statin therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University
  Xi'an, Shaanxi, China Recruiting
• The First Affiliated Hospital of Xi 'an Jiaotong University
  Xi'an, China Recruiting

Study contacts

• Study coordinator: Yue Yu
• Email: yueyu05@163.com
• Phone: 0086-85323810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.