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Many guidelines recommend the preferential use of GLP-1 RA after single drug or multiple oral hypoglycemic drugs and basic insulin therapy for poor glycemic control. However, the clinical responsiveness to GLP-1 RA varies among patients with T2DM. It has been reported that genetic factors are the important reasons for individual variation in therapeutic response of antidiabetic drugs. At present, dozens of gene loci related to therapeutic response of antidiabetic drugs have been screened, which are of great clinical significance in guiding clinical individualized treatment, improving the efficacy and safety of drugs, and reducing the drug costs.
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months. The patients were visited at moths 0, 3, and 6, and medical histories, physical examinations, and routine clinical laboratory tests were performed during these visits. The general anthropometric parameters considered for this study were height (m), weight (kg), and waist and hip circumferences (cm) at baseline, 3 months and 6months after exenatide treatment. After an overnight fast, venous blood samples were obtained both in the fasting state and 2 h later during a standard 75-g oral glucose tolerance test. Parameters were measured at baseline, the end of months 3 and 6 after administration of exenatide.
Peripheral blood was collected at follow-up and genomic DNA was extracted from peripheral blood leucocytes. We further explored the association of gene polymorphisms with the therapeutic effect of GLP-1 RA in patients with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP-1 RA therapy | Experimental | GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 receptor agonist | Drug | GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline HbA1c at 1 month | In order to observe the change from baseline HbA1c at 1 month after GLP-1 RA treatment | 1 month after GLP-1 RA treatment |
| Change from baseline FPG at 1 month | In order to observe the change from baseline FPG at 1 month after GLP-1 RA treatment | 1 month after GLP-1 RA treatment |
| Change from baseline PPG at 1 month | In order to observe the change from baseline PPG at 1 month after GLP-1 RA treatment | 1 month after GLP-1 RA treatment |
| Change from baseline serum lipids at 1 month | In order to observe the change from baseline serum lipids at 1 month after GLP-1 RA treatment | 1 month after GLP-1 RA treatment |
| Change from baseline HbA1c at 3 month | In order to observe the change from baseline HbA1c at 3 month after GLP-1 RA treatment | 3 month after GLP-1 RA treatment |
| Change from baseline FPG at 3 month | In order to observe the change from baseline FPG at 3 month after GLP-1 RA treatment | 3 month after GLP-1 RA treatment |
| Change from baseline PPG at 3 month | In order to observe the change from baseline PPG at 3 month after GLP-1 RA treatment | 3 month after GLP-1 RA treatment |
| Measure | Description | Time Frame |
|---|---|---|
| incidence and severity of possible adverse reaction within 1 month after GLP-1 RA treatment | To evaluate the incidence and severity of possible adverse reaction within 1 month after GLP-1 RA treatment, including gastrointestinal reaction and hypoglycemia | 1 month after GLP-1 RA treatment |
| incidence and severity of possible adverse reaction within 3 month after GLP-1 RA treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renhao Wang, Ph.D | The Affiliated Hospital of Xuzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology | Xuzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Change from baseline serum lipids at 3 month | In order to observe the change from baseline serum lipids at 3 month after GLP-1 RA treatment | 3 month after GLP-1 RA treatment |
| Change from baseline HbA1c at 6 month | In order to observe the change from baseline HbA1c at 6 month after GLP-1 RA treatment | 6 month after GLP-1 RA treatment |
| Change from baseline FPG at 6 month | In order to observe the change from baseline FPG at 6 month after GLP-1 RA treatment | 6 month after GLP-1 RA treatment |
| Change from baseline PPG at 6 month | In order to observe the change from baseline PPG at 6 month after GLP-1 RA treatment | 6 month after GLP-1 RA treatment |
| Change from baseline serum lipids at 6 month | In order to observe the change from baseline serum lipids at 6 month after GLP-1 RA treatment | 6 month after GLP-1 RA treatment |
To evaluate the incidence and severity of possible adverse reaction within 3 month after GLP-1 RA treatment, including gastrointestinal reaction and hypoglycemia |
| 3 month after GLP-1 RA treatment |
| incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment | To evaluate the incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment, including gastrointestinal reaction and hypoglycemia | 6 month after GLP-1 RA treatment |
| D004700 | Endocrine System Diseases |