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NCT Number: NCT06684106

Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ursodeoxycholic acid (UDCA) 500 mg

Drug

UDCA together with statin in eligible participants

Other names: Ursodeoxycholic Acid, UDCA

Placebo

Drug

placebo together with statin in ASCVD patients

Primary outcomes

  1. HbA1c

    Time frame: 6 months after randomization

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

Secondary outcomes

  1. Concentration of fasting blood glucose

    Time frame: 6 months after randomization

    The concentration of fasting blood glucose was measured and serum was extracted for laboratory testing.

  2. Concentration of fasting islets

    Time frame: 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.

  3. Concentration of blood lipid

    Time frame: 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)".

  4. Body composition analysis Fat mass

    Time frame: 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"

  5. Body composition analysis Muscle mass

    Time frame: 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Yue Wu, Professor

CONTACT

[email protected]

0086-029-8532-3664

Yue Yu

CONTACT

[email protected]

0086-85323810

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial

Acronym: URSTAR

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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