Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
About this trial
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
This trial accepts healthy volunteersQualifiers
Age 18-75 years old.
LDL-C≥3.4mmol/l (130 mg/dL).
Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol).
Voluntarily sign informed consent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ursodeoxycholic acid (UDCA) 500 mg
DrugUDCA together with statin in eligible participants
Placebo
Drugplacebo together with statin in ASCVD patients
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Ursodeoxycholic acid groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
HbA1c
Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year
Time frame
6 months after randomizationSecondary outcomes
1
Concentration of fasting blood glucose
The concentration of fasting blood glucose was measured and serum was extracted for laboratory testing.
Time frame
6 months after randomization2
Concentration of fasting islets
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 randomization3
Concentration of blood lipid
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 randomization4
Body composition analysis Fat mass
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 randomizationSponsors and contacts
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Source ClinicalTrials.gov