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

Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Glucose Intolerance; Hyperlipidemia; Statin Therapy; Ursodeoxycholic Acid
• Intervention / Treatment: Drug: Ursodeoxycholic acid (UDCA) 500 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue Wu, Professor; Phone Number: 0086-029-8532-3664; Email: imyuewu@qq.com
• Study Contact Backup: Name: Yue Yu; Phone Number: 0086-85323810; Email: yueyu05@163.com

Study Locations

• China
  • Xi'an, China
    • Recruiting
    • The First Affiliated Hospital of Xi 'an Jiaotong University
    • Contact: Yue Wu; Phone Number: 0086-85323810; Email: imyuewu@qq.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Yue Wu; Phone Number: 0086-029-8532-3664; Email: imyuewu@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ursodeoxycholic acid group; Ursodeoxycholic acid (UDCA) 500 mg: This group of participants receive UDCA 500mg per day.	Drug: Ursodeoxycholic acid (UDCA) 500 mg; UDCA together with statin in eligible participants; Other Names: UDCA; Ursodeoxycholic Acid
Placebo Comparator: placebo group; This group of participants receive placebo.	Drug: Placebo; placebo together with statin in ASCVD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year	6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of fasting blood glucose	The concentration of fasting blood glucose was measured and serum was extracted for laboratory testing.	6 months after randomization
Concentration of fasting islets	The concentration of fasting islets was measured and serum was extracted for laboratory testing. we use the level of physiological parameter to describe the concentration of fasting islets.	6 months after randomization
Concentration of blood lipid	The concentration of blood lipid was measured and serum was extracted for laboratory testing.we use the level of physiological parameter to describe the concentration of blood lipid, including "the level of triglycerides","the level of low-density lipoprotein", "the level of high-density lipoprotein", "the level of total cholesterol" ,"the level of Lipoprotein(a)".	6 months after randomization
Body composition analysis Fat mass	The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g."Fat mass"	6 months after randomization
Body composition analysis Muscle mass	The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g. "Muscle mass".	6 months after randomization

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Zuyi Yuan, Professor, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Dyslipidemias; Lipid Metabolism Disorders; Hyperglycemia; Nutritional and Metabolic Diseases; Glucose Intolerance; Hyperlipidemias; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Cholanes; Ursodeoxycholic Acid
• Other Study ID Numbers: XJTU1AF2023LSK-149-01; CSCF2022B04 (Other Grant/Funding Number: 2022 Chinese Society of Cardiology's Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to participant privacy and ethical restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No