A Phase 2/3 interventional study of UDCA in Diabetes Mellitus, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 2/3, Interventional, and Treatment
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
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This group of participants receive UDCA 500mg per day.
Drug: UDCA
This group of participants receive placebo.
Drug: UDCA
UDCA vs. placebo together with statin in ASCVD patients
Also known as: Ursodeoxycholic acid
Changes of HbA1c
Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year
Time frame: 12 months after enrollment
Concentration of blood lipid
Time frame: 12 months after enrollment
Concentration of fasting blood glucose
Time frame: 12 months after enrollment
Concentration of fasting islets
Time frame: 12 months after enrollment
Concentration of bile acids
Time frame: 12 months after enrollment
Rate of MACE
Time frame: 12 months after enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ursodeoxycholic Acid
First Affiliated Hospital Xi'an Jiaotong University →