Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin
Primary Purpose
Diabetes Mellitus
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
UDCA
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
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;
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
UDCA 500mg per day
Placebo
Arm Description
This group of participants receive UDCA 500mg per day.
This group of participants receive placebo.
Outcomes
Primary Outcome Measures
Changes of HbA1c
Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year
Secondary Outcome Measures
Concentration of blood lipid
Concentration of fasting blood glucose
Concentration of fasting islets
Concentration of bile acids
Rate of MACE
Full Information
NCT ID
NCT05500937
First Posted
December 10, 2021
Last Updated
September 26, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05500937
Brief Title
Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin
Official Title
Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin-A Multicenter, Prospective, Random Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UDCA 500mg per day
Arm Type
Active Comparator
Arm Description
This group of participants receive UDCA 500mg per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group of participants receive placebo.
Intervention Type
Drug
Intervention Name(s)
UDCA
Other Intervention Name(s)
Ursodeoxycholic acid
Intervention Description
UDCA vs. placebo together with statin in ASCVD patients
Primary Outcome Measure Information:
Title
Changes of HbA1c
Description
Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year
Time Frame
12 months after enrollment
Secondary Outcome Measure Information:
Title
Concentration of blood lipid
Time Frame
12 months after enrollment
Title
Concentration of fasting blood glucose
Time Frame
12 months after enrollment
Title
Concentration of fasting islets
Time Frame
12 months after enrollment
Title
Concentration of bile acids
Time Frame
12 months after enrollment
Title
Rate of MACE
Time Frame
12 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqing She
Phone
17782959686
Email
jianqingshe@xjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuyi Yuan
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Wu, Professor
Phone
0086-029-8532-3664
Email
imyuewu@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin
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