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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | 23 patients who will receive 2nd generation sulfonylureas only, for three months. | |
| Nicorandil Arm | Experimental | 23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorandil 10 MG | Drug | Patients will receive oral Nicorandil 10 MG twice daily in addition to 2nd generation sulfonylureas , for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c level | Change in HbA1c (From baseline to 12 weeks) | The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. |
| Change in body weight. | Change in body weight (From baseline to 12 weeks). | The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. |
| Change in Body mass index (BMI) | Change in Body mass index (BMI) (From baseline to 12 weeks). | The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. |
| Change in Visceral adiposity index (VAI). | Change in Visceral adiposity index (VAI) (From baseline to 12 weeks). | The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels. | Assessment of Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide levels by ELISA Kits according to manufacturer's instructions. | The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merna Mohamed Seddik Ali | Contact | +201026064628 | merna198ali@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Tanta University | Recruiting | Tanta | 31511 | Egypt |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020108 | Nicorandil |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D009930 | Organic Chemicals |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
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| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000147 |
| Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |