Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperlipidemia Ursodeoxycholic Acid Statin Therapy Glucose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ursodeoxycholic acid group

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

Group Type EXPERIMENTAL

Ursodeoxycholic acid (UDCA) 500 mg

Intervention Type DRUG

UDCA together with statin in eligible participants

placebo group

This group of participants receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo together with statin in ASCVD patients

Interventions

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Ursodeoxycholic acid (UDCA) 500 mg

UDCA together with statin in eligible participants

Intervention Type DRUG

Placebo

placebo together with statin in ASCVD patients

Intervention Type DRUG

Other Intervention Names

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Ursodeoxycholic Acid UDCA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes