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Clinical Trials in China / NCT06684106
Recruiting Not applicable

Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

NCT06684106 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Phase
Not applicable
Started
2024-11-25
Last updated
2026-06-30

Condition(s) studied

HyperlipidemiaUrsodeoxycholic AcidStatin TherapyGlucose Intolerance

Investigational drug(s) / intervention(s)

Ursodeoxycholic acid (UDCA) 500 mgPlacebo

Ursodeoxycholic acid (UDCA) 500 mg: UDCA together with statin in eligible participants

Placebo: placebo together with statin in ASCVD patients

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (2)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06684106 on ClinicalTrials.gov ↗ ← All trials in China