Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

NCT06684106 | Recruiting

• 2 other identifiers: XJTU1AF2023LSK-149-01CSCF2022B04
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hyperlipidemia; Ursodeoxycholic Acid; Statin Therapy; Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year

  6 months after randomization

Secondary Outcomes (5)

• Concentration of fasting blood glucose

  6 months after randomization

• Concentration of fasting islets

  6 months after randomization

• Concentration of blood lipid

  6 months after randomization

• Body composition analysis Fat mass

  6 months after randomization

• Body composition analysis Muscle mass

  6 months after randomization

Study Arms (2)

Ursodeoxycholic acid group

EXPERIMENTAL

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

Drug: Ursodeoxycholic acid (UDCA) 500 mg

placebo group

PLACEBO COMPARATOR

This group of participants receive placebo.

Drug: Placebo

Interventions

Ursodeoxycholic acid (UDCA) 500 mg DRUG

UDCA together with statin in eligible participants

Also known as: Ursodeoxycholic Acid, UDCA

Ursodeoxycholic acid group

Placebo DRUG

placebo together with statin in ASCVD patients

placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old.
• LDL-C≥3.4mmol/l (130 mg/dL).
• Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol).
• Voluntarily sign informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (2)

Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias; Glucose Intolerance

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Zuyi Yuan, Professor

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Yue Yu

CONTACT

0086-85323810; yueyu05@163.com

Yue Wu, Professor

CONTACT

0086-029-8532-3664; imyuewu@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 12, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CN (2)