Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance (URSTAR)

Xi'an Jiaotong University

Status: Enrolling

Conditions: Hyperlipidemia; Ursodeoxycholic Acid; Glucose Intolerance; Statin Therapy

Treatments: Drug: Placebo; Drug: Ursodeoxycholic acid (UDCA) 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06684106

CSCF2022B04 (Other Grant/Funding Number)

XJTU1AF2023LSK-149-01

Details and patient eligibility

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

Ursodeoxycholic acid group

Experimental group

Description:

Ursodeoxycholic acid (UDCA) 500 mg: This group of participants receive UDCA 500mg per day.

Treatment:

Drug: Ursodeoxycholic acid (UDCA) 500 mg

placebo group

Placebo Comparator group

Description:

This group of participants receive placebo.

Treatment:

Drug: Placebo