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

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    First Affiliated Hospital Xi'an Jiaotong University
Updated on 16 October 2022
cardiovascular disease
type 2 diabetes mellitus
fasting blood glucose
hemoglobin a1c
glycosylated hemoglobin
hmg-coa reductase inhibitors


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.

Condition Diabetes Mellitus
Treatment UDCA
Clinical Study IdentifierNCT05500937
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
Last Modified on16 October 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note