NCT06684106招募中不适用
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- HbA1c
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years old.
- •LDL-C≥3.4mmol/l (130 mg/dL).
- •Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol).
- •Voluntarily sign informed consent.
排除标准
- •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 ≥
- •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.
研究组 & 干预措施
Ursodeoxycholic acid group
Experimental
Ursodeoxycholic acid (UDCA) 500 mg: This group of participants receive UDCA 500mg per day.
干预措施: Ursodeoxycholic acid (UDCA) 500 mg (Drug)
placebo group
Placebo Comparator
This group of participants receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: 6 months after randomization
Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year
次要结局
- 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)
研究者
研究点 (3)
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