Clinical trial NCT06684106: Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance
Official title: Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperlipidemia
Ursodeoxycholic Acid
Statin Therapy
Glucose Intolerance
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Concentration of fasting blood glucose
timeFrame: 6 months after randomization
measure: Concentration of fasting islets
timeFrame: 6 months after randomization
measure: Concentration of blood lipid
timeFrame: 6 months after randomization
measure: Body composition analysis Fat mass
timeFrame: 6 months after randomization
measure: Body composition analysis Muscle mass
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Zuyi Yuan, Professor
role: STUDY_CHAIR
References: