Ursodeoxycholic acid (UDCA) 500 mg
DrugUDCA together with statin in eligible participants
Other names: Ursodeoxycholic Acid, UDCA
NCT Number: NCT06684106
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
UDCA together with statin in eligible participants
Other names: Ursodeoxycholic Acid, UDCA
placebo together with statin in ASCVD patients
Time frame: 6 months after randomization
Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year
Time frame: 6 months after randomization
The concentration of fasting blood glucose was measured and serum was extracted for laboratory testing.
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.
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)".
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"
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".
Contact information is provided by the study sponsor or research team.
Yue Wu, Professor
CONTACT
Yue Yu
CONTACT
First Affiliated Hospital Xi'an Jiaotong University
Other
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial
Acronym: URSTAR
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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