Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin

NCT ID: NCT05500937

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-12-31

Brief Summary

At present, it is recognized that statins are the cornerstone of treatment for the prevention of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD); However, at the same time, the increased risk of long-term glucose tolerance and type 2 diabetes mellitus caused by statin therapy has attracted wide attention. The investigators' recent study found that the levels of glycosylated hemoglobin, insulin and C-peptide increased significantly with the extension of follow-up time in patients with hyperlipidemia. At the same time, serum and fecal bile acid metabolism profiles, especially secondary bile acid metabolism, were extensively changed, especially in ursodeoxycholic acid (UDCA), suggesting that the decrease of UDCA is a possible mechanism for statins to induce side effects of diabetes. According to this hypothesis, ursodeoxycholic acid combined with statins may improve the abnormal glucose tolerance caused by statins and maximize the benefit of statins. This study is a multicenter, prospective, randomized, parallel, double-blind placebo-controlled, cohort study. Taking ASCVD patients as the research object, the investigators will compare the changes of glycosylated hemoglobin, fasting blood glucose, fasting insulin, C-peptide and metabolomic indexes before and after the use of ursodeoxycholic acid combined with atorvastatin and atorvastatin alone and during follow-up, Further evaluate the changes of blood glucose related indexes before and after the use of ursodeoxycholic acid combined with atorvastatin and atorvastatin alone, clarify the possible mechanism and specific treatment targets of abnormal glucose tolerance caused by statin, and put forward a possible alternative treatment for the disorder of glucose metabolism caused by statin.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

UDCA 500mg per day

This group of participants receive UDCA 500mg per day.

Group Type: ACTIVE_COMPARATOR

UDCA

Intervention Type: DRUG

UDCA vs. placebo together with statin in ASCVD patients

Placebo

This group of participants receive placebo.

Group Type: PLACEBO_COMPARATOR

UDCA

Intervention Type: DRUG

UDCA vs. placebo together with statin in ASCVD patients

Interventions

UDCA

UDCA vs. placebo together with statin in ASCVD patients

Intervention Type: DRUG

Other Intervention Names

Ursodeoxycholic acid

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old and < 80 years old, regardless of gender;
• For those who had indications for taking statins for more than half a year, glycosylated hemoglobin increased by more than 0.5 and > 6.1% compared with half a year ago;
• Agree to accept the study treatment plan and voluntarily sign the informed consent form.

Exclusion Criteria

• previous diagnosis of diabetes mellitus;
• Received hypoglycemic drug treatment;
• The level of abdominal blood glucose at baseline was ≥ 7mmol / L;
• Need to take glucocorticoids for a long time;
• Acute myocardial infarction and stroke occurred in the last 6 months;
• Severe liver dysfunction;
• Glomerular filtration rate (EGFR) < 30ml / min / 1.73m2 (MDRD formula);
• Malignant tumor;
• Blood system diseases;
• Acute or severe systemic infection;
• Women during pregnancy, lactation and preparation for pregnancy;
• Alcohol and other drug addicts and mental patients;
• Patients who are participating in other clinical studies or withdraw from less than 1 month;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zuyi Yuan

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianqing She

Role: CONTACT

jianqingshe@xjtu.edu.cn

17782959686

Facility Contacts

Yue Wu, Professor

Role: primary

imyuewu@qq.com

0086-029-8532-3664

Other Identifiers

XJTU1AF2021CRF-007

Identifier Type: -

Identifier Source: org_study_id