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| Name | Class |
|---|---|
| Menoufia University | OTHER |
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Diabetes mellitus (DM) is a complex metabolic disorder characterized by hyperglycemia and abnormalities in carbohydrate, fat, and protein metabolism. Despite the advancement in anti-diabetic drug therapy, most patients fail to achieve optimal glycemic control. This highlights the need for more effective strategies to control type 2 diabetes mellitus.
Nitazoxanide (NTZ), a broad-spectrum anti-infective drug with activity against various protozoa, helminthes, bacteria, and viruses, was identified as peroxisome proliferative activated receptor gamma (PPARγ) agonist using one dimensional drug profile matching. Additionally, it improved insulin sensitivity in insulin-resistant type 2 diabetic rats. Therefore, this study is designed to evaluate the efficacy of nitazoxanide as adjunctive therapy in patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | No Intervention | 35 Patients with type 2 diabetes receiving treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin). | |
| Group 2 | Experimental | 35 Patients with type 2 diabetes receiving nitazoxanide 500 mg orally twice daily in addition to metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | Nitazoxanide oral capsules 500 mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | Fasting blood glucose and glycated hemoglobin | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance | fasting insulin level with HOMA-IR calculation | 12 weeks |
| Lipid profile | Serum levels of total cholesterol, LDL, HDL, and triglycerides |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman Ghonaim, Assistant lecturer | Contact | +20-010-970-821-57 | eman.ghonim@pharm.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Eman Ghonaim | Assistant Lecturer, Faculty of Pharmacy, Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Tanta University | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40815384 | Derived | Ghonaim EM, Ibrahim OM, Hegazy SK, Farrag WF, Badr HR. Repurposing nitazoxanide in type 2 diabetes mellitus: a randomized controlled trial. Endocrine. 2025 Nov;90(2):596-604. doi: 10.1007/s12020-025-04387-5. Epub 2025 Aug 15. |
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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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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
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| 12 weeks |
| Serum levels of A-kinase anchoring protein 1 | 12 weeks |
| Serum levels of asprosin | 12 weeks |
| Faculty of Medicine, Menoufia University | Recruiting | Shibīn al Kawm | Menoufia | 32511 | Egypt |
|
| D004700 | Endocrine System Diseases |