Actively Recruiting
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2025-09-19
128
Participants Needed
2
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old
- LDL cholesterol 6.4 mmol/L (130 mg/dL)
- Glycosylated hemoglobin (HbA1c) 4.0% (42 mmol/mol)
- Voluntarily sign informed consent
You will not qualify if you...
- Previous diagnosis of diabetes or prediabetes
- Past or current use of hypoglycemic drugs
- Use of statin lipid-lowering drugs within 3 months before enrollment
- Taking 3 or more oral drugs
- History of atherosclerotic cardiovascular disease (ASCVD) including myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 1 year, or symptomatic peripheral vascular disease
- Active liver disease or severe liver problems
- Difficult to control hypertension (systolic 180 mmHg or diastolic 110 mmHg despite treatment)
- Estimated glomerular filtration rate (eGFR) 30 mL/min/1.73m2
- New York Heart Association Class IV heart failure or left ventricular ejection fraction < 25%
- Significant arrhythmia resistant to treatment within 3 months prior
- Acute or severe systemic infection or serious diseases like blood disorders, autoimmune disorders, cancer, psychiatric conditions, or other unstable conditions
- Scheduled for surgery within 6 months
- Pregnant, breastfeeding, or planning pregnancy during or within 6 months after the study
- Alcohol or drug addiction
- Secondary hypercholesterolemia (e.g., hypothyroidism, nephrotic syndrome)
- History of allergic reaction to study drugs or similar chemicals
- Family history of homozygous familial hypercholesterolemia
- Currently enrolled in another clinical trial or unable to follow up for 6 months
- Any condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
2
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, China
Actively Recruiting
Research Team
Y
Yue Yu
CONTACT
Y
Yue Wu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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