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| ID | Type | Description | Link |
|---|---|---|---|
| CSCF2022B04 | Other Grant/Funding Number | 2022 Chinese Society of Cardiology's Foundation |
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The purpose of this clinical trial is to understand whether the drug Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in participants with hyperlipidemia who are taking statins. It will also assess the safety of UDCA. The primary questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ursodeoxycholic acid group | Experimental | Ursodeoxycholic acid (UDCA) 500 mg: This group of participants receive UDCA 500mg per day. |
|
| placebo group | Placebo Comparator | This group of participants receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic acid (UDCA) 500 mg | Drug | UDCA together with statin in eligible participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of fasting blood glucose | The concentration of fasting blood glucose was measured and serum was extracted for laboratory testing. | 6 months after randomization |
| Concentration of fasting islets |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Yu | Contact | 0086-85323810 | yueyu05@163.com | |
| Yue Wu, Professor | Contact | 0086-029-8532-3664 | imyuewu@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zuyi Yuan, Professor | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
Individual participant data will not be shared due to participant privacy and ethical restrictions.
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Placebo | Drug | placebo together with statin in ASCVD patients |
|
The concentration of fasting islets was measured and serum was extracted for laboratory testing. we use the level of physiological parameter to describe the concentration of fasting islets.
| 6 months after randomization |
| Concentration of blood lipid | The concentration of blood lipid was measured and serum was extracted for laboratory testing.we use the level of physiological parameter to describe the concentration of blood lipid, including "the level of triglycerides","the level of low-density lipoprotein", "the level of high-density lipoprotein", "the level of total cholesterol" ,"the level of Lipoprotein(a)". | 6 months after randomization |
| Body composition analysis Fat mass | The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g."Fat mass" | 6 months after randomization |
| Body composition analysis Muscle mass | The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g. "Muscle mass". | 6 months after randomization |
| The First Affiliated Hospital of Xi 'an Jiaotong University | Recruiting | Xi'an | China |
|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |