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This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | this group will include 23 patients who will receive metformin 2gm/day. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be up titrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks . | |
| Nicorandil group | Active Comparator | this group will include 23 patients who will receive a combination of metformin 2g/day and nicorandil 10 mg twice daily. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be uptitrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorandil 10 MG Oral Tablet | Drug | Nicorandil 10 MG oral tablet twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| prevention of progression of kidney disease as measured by KDIGO. | Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in the serum concentrations of Kidney injury molecule 1(Kim-1). | Venous blood will be collected before treatment and after 12 week . | 12 weeks |
| change in the serum concentrations of Interleukin 18 (IL-18). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed A El-hazzab | Contact | 201151998914 | mohamed150556@pharm.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | EL Gharbia | Egypt |
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| ID | Term |
|---|---|
| D020108 | Nicorandil |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D009930 | Organic Chemicals |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
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Venous blood will be collected before treatment and after 12 week .
| 12 weeks |
| change in the serum concentrations of Nitric oxide (NO). | Venous blood will be collected before treatment and after 12 week . | 12 weeks |
| D000147 |
| Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |