Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called Ursodeoxycholic acid (UDCA) can help people who have high cholesterol (hyperlipidemia) and are taking statins, a common type of cholesterol-lowering drug. The main goal is to see if UDCA can prevent glucose intolerance, which means the body has trouble processing sugar, a potential side effect of statin therapy. Additionally, the trial will look at the safety of UDCA. Participants will take either UDCA with a statin or a placebo (a dummy pill) daily for six months, with follow-up visits scheduled at specific points throughout the study.

To be eligible for this trial, participants must be between 40 and 75 years old, have specific cholesterol levels, and not have diabetes or use any blood sugar-lowering medications. Those who qualify will be asked to sign consent and will have their health monitored during the study. It’s important to note that individuals with certain health conditions, such as severe liver disease or heart problems, or those who are pregnant or trying to become pregnant, cannot participate. This trial is currently looking for volunteers, and it aims to provide insights into managing cholesterol treatment and its effects on blood sugar levels.

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Eligibility criteria

• Inclusion Criteria:
• • Age 40-75 years old.
• • LDL-C≥4.1mmol/l (160 mg/dL).
• • Glycosylated hemoglobin \< 6.0% (39 mmol/mol).
• • Voluntarily sign informed consent.
• Exclusion Criteria:
• • Previous diagnosis of diabetes or prediabetes.
• • Past or current use of hypoglycemic drugs.
• • Previous lipid-lowering treatment with lipid-lowering drugs or other means (such as traditional Chinese medicine or omega-3 fatty acids).
• • Taking glucocorticoid drugs or using birth control drugs.
• • 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) \> 3 × upper limit of normal (ULN) or total bilirubin \>2 × 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, who have withdrawn within the past month, or who cannot adhere to 6-month follow-up
• • Any condition that the investigator considers unsuitable for participation.