Actively Recruiting
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2025-09-19
128
Participants Needed
2
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in people with hyperlipidemia who are taking statin medications. The study also aims to assess the safety of UDCA in these participants. The main questions are whether UDCA reduces the occurrence of glucose intolerance and other adverse events in those using oral statins. Participants will be randomly assigned to receive either UDCA 500 mg daily or a placebo, both combined with atorvastatin, for a period of six months. Follow-up visits are scheduled on day 40, day 110, and day 180 to monitor participants and collect health data. Throughout the study, participants will have various measurements taken, including HbA1c levels at six months as the primary outcome. Secondary outcomes include fasting blood glucose, fasting islets concentration, blood lipids, and body composition measurements such as fat and muscle mass. These assessments help researchers understand the effects and safety of UDCA alongside statin therapy during the six-month participation period.
CONDITIONS
Brief 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 level 6.4 mmol/L (130 mg/dL)
- Glycosylated hemoglobin 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
- Oral use of statin lipid-lowering drugs within three months before enrollment
- Use of three or more combined oral drugs
- History of atherosclerotic cardiovascular disease within one year
- Active liver disease or severe hepatic insufficiency
- Difficult to control hypertension (systolic 180 mmHg or diastolic 110 mmHg despite treatment)
- Estimated glomerular filtration rate 30 mL/min/1.73m2 or less
- NYHA Class IV heart failure or left ventricular ejection fraction less than 25%
- Recent clinically significant arrhythmia
- Acute or severe systemic infection or serious unstable conditions
- Scheduled for surgery within six months
- Pregnant, breastfeeding, or planning pregnancy during the study or within six months after
- Alcohol or drug addiction
- Secondary hypercholesterolemia such as hypothyroidism or nephrotic syndrome
- History of allergic reactions to study drugs or similar chemicals
- Family history of homozygous familial hypercholesterolemia
- Currently enrolled in another clinical trial or unable to adhere to six-month follow-up
- Any condition the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take either Ursodeoxycholic acid (UDCA) 500 mg or a placebo daily together with statin medication.
Regular visits during the 6 months of treatment
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
Y
Yue Wu, Professor
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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