Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

Not Applicable

Recruiting

• Conditions: Hyperlipidemia; Ursodeoxycholic Acid; Statin Therapy; Glucose Intolerance
• Interventions: Drug: Ursodeoxycholic acid (UDCA) 500 mg; Drug: Placebo

• Registration Number: NCT06684106
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Study Start: 2024-11-25
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-11-11
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ursodeoxycholic acid group	Ursodeoxycholic acid (UDCA) 500 mg	Ursodeoxycholic acid (UDCA) 500 mg: This group of participants receive UDCA 500mg per day.
placebo group	Placebo	This group of participants receive placebo.

Primary Outcome Measures

Name	Time	Method
HbA1c	6 months after randomization	Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year

Secondary Outcome Measures

Name	Time	Method
Concentration of fasting blood glucose	6 months after randomization	The concentration of fasting blood glucose was measured and serum was extracted for laboratory testing.
Concentration of fasting islets	6 months after randomization	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.
Concentration of blood lipid	6 months after randomization	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)".
Body composition analysis Fat mass	6 months after randomization	The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g."Fat mass"
Body composition analysis Muscle mass	6 months after randomization	The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g. "Muscle mass".

Trial Locations

Locations (1)

Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China