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The goal of this clinical trial is to learn about inour study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration.
The main question[s] it aims to answer are:
Chiglitazar Sodium for lipid profile abnormalities and its associated effective lipid molecular biomarkers have never been studied in patients with T2DM. Therefore, our study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration using ultra-high performance liquid chromatography-Tandem quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS). For completeness, we also evaluated the effects of Chiglitazar Sodium treatment on metabolic markers associated with T2DM and its association with lipidomic changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar sodium | Drug | In patients with type 2 diabetes mellitus (T2DM), on the basis of one or two oral hypoglycemic agents combination with Chiglitazar sodium. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change in HbA1c from baseline | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Serum lipid profile | Changes from baseline in sphingomyelin (SMs), ceramide (CER), lysophosphatidylcholine (LPC), phosphatidylethanolamine (PEs), lysophosphatidylethanolamine (LPEs), and phosphatidylcholine (PC) | 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 200080 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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