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

NCT05500937 | Unknown Phase 2

• 1 other identifier: XJTU1AF2021CRF-007
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes of HbA1c

  Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year

  12 months after enrollment

Secondary Outcomes (5)

• Concentration of blood lipid

  12 months after enrollment

• Concentration of fasting blood glucose

  12 months after enrollment

• Concentration of fasting islets

  12 months after enrollment

• Concentration of bile acids

  12 months after enrollment

• Rate of MACE

  12 months after enrollment

Study Arms (2)

UDCA 500mg per day

ACTIVE COMPARATOR

This group of participants receive UDCA 500mg per day.

Drug: UDCA

Placebo

PLACEBO COMPARATOR

This group of participants receive placebo.

Drug: UDCA

Interventions

UDCA DRUG

UDCA vs. placebo together with statin in ASCVD patients

Also known as: Ursodeoxycholic acid

Placebo; UDCA 500mg per day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Zuyi Yuan

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Jianqing She

CONTACT

17782959686; jianqingshe@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: August 15, 2022
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-08

Locations

CN (1)