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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
128 (estimated)
Sponsor
First Affiliated Hospital Xi'an Jiaotong University · Other
Who this trial is looking for
This trial is looking for adults with high cholesterol who are taking statin medications and may be at risk for developing glucose intolerance. Participants will take Ursodeoxycholic acid along with their usual medication for six months and attend follow-up visits during this time.
Are You a Good Fit for This Trial?
Must be takingAtorvastatin
Rules you outDiabetesHeart diseaseLiver diseaseKidney disease
You may be able to join if
I am between 18 and 75 years old.
I have high cholesterol levels.
I have a healthy blood sugar level.
I can give my consent to join this study.
You may not be able to join if
I have been diagnosed with diabetes or prediabetes.
I have used medications for blood sugar control.
I have taken any statin medications in the last three months.
I have had a heart attack or stroke in the past year.
I have active liver disease.
I have very high blood pressure.
I have kidney problems.
I am pregnant, breastfeeding, or trying to get pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility Criteria
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…
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.
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