Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University