Ursodeoxycholic acid helps prevent glucose intolerance in statin users
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial
This study is testing if taking Ursodeoxycholic acid along with a common cholesterol medication can help people with high cholesterol avoid problems with blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 2 sites (Xi'an, Shaanxi and 1 other locations) |
| Trial ID | NCT06684106 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-75 with high LDL cholesterol levels but without a history of diabetes or prediabetes.
Not a fit: Patients with a prior diagnosis of diabetes or those currently using hypoglycemic medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help patients manage glucose levels better while on statin therapy, potentially reducing the risk of diabetes.
How similar studies have performed: While the specific approach of using UDCA in this context may be novel, similar studies have explored the effects of adjunct therapies on statin-induced side effects with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Xi'an, Shaanxi and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.