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With the improvement of people's living standard, the prevalence of Diabetes is increasing year by year. In present, 350 million people worldwide are suffering from diabetes, and by 2035, there will be as high as 600 million. Diabetes causes a variety of complications, including diabetic nephropathy, which is one of the most common complications of Diabetes. Diabetic nephropathy is a microvascular complication of diabetes. Microalbuminuria and glomerular filtration rate decrease are the main manifestation. Even more, it can progress to end-stage renal changes. Data showed that diabetic nephropathy accounts for about 40% of patients with end-stage renal disease receiving renal replacement therapy.
However, the treatment of diabetic nephropathy is still lacking. In the past 40 years, few drugs have been proven to ameliorate the progression of diabetic nephropathy. Even though, the renal function of a large number of diabetic nephropathy patients is gradually deteriorating. Therefore, it is urgent to find a therapeutic drug that acts on different targets.
Trimetazidine is a piperazine derivative. It is mainly used in the treatment of stable angina pectoris. Its safety has been well verified. In recent years, the role of trimetazidine in acute renal damage has been widely reported. A large number of studies have shown that trimetazidine can reduce the effect of contrast agent on renal function and reduce the incidence of contrast nephropathy. There fore, Trimetazidine is a promising drug for delaying the progression of diabetic nephropathy.
In the present study, there will be 2 groups last for 6 months. One is the control group, who will not receive trimetazidine and the another is the trimetazidine group, who will receive the treatment of trimetazidine, 35mg bid orally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Blank group | |
| Trimetazidine group | Experimental | The participates received treatments of trimetazidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimetazidine | Drug | Oral,35mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of UACR levels at 6 months to baseline UACR | UACR(6 M)/UACR(base) | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine | Serum creatinine | 6 month |
| 24h urine protein level | 24h urine protein level | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Proportion of patients with UACR>300 mg/g in the population at 6 months | Proportion of patients with UACR>300 mg/g in the population at 6 months | 6 month |
| Proportion of patients with UACR >30mg/g and <300 mg/g in the population at 6 months | Proportion of patients with UACR >30mg/g and <300 mg/g in the population at 6 months | 6 month |
| Ratio of UACR levels at 3 months to baseline UACR | Ratio of UACR levels at 3 months to baseline UACR | 3 month |
| Ratio of UACR levels at 1 months to baseline UACR | Ratio of UACR levels at 1 months to baseline UACR | 1 month |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |