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Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

NCT06684106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Hyperlipidemia
  • Ursodeoxycholic Acid
  • Statin Therapy
  • Glucose Intolerance

Interventions

DRUG

Ursodeoxycholic acid (UDCA) 500 mg

UDCA together with statin in eligible participants

DRUG

Placebo

placebo together with statin in ASCVD patients

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Zuyi Yuan, Professor · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2026-11-11
Completion
2027-06-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06684106 on ClinicalTrials.gov