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

Diabetes Mellitus Clinical Trial

Official title:

Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin-A Multicenter, Prospective, Random Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500937
• Other study ID #: XJTU1AF2021CRF-007
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jianqing She
• Phone: 17782959686
• Email: jianqingshe[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance

Intervention

Drug:
• UDCA
UDCA vs. placebo together with statin in ASCVD patients

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of HbA1c	Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year	12 months after enrollment
Secondary	Concentration of blood lipid		12 months after enrollment
Secondary	Concentration of fasting blood glucose		12 months after enrollment
Secondary	Concentration of fasting islets		12 months after enrollment
Secondary	Concentration of bile acids		12 months after enrollment
Secondary	Rate of MACE		12 months after enrollment