Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus
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 (PPARĪ³) 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.
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | January 1, 2025 |
| Est. primary completion date | October 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Glycated hemoglobin (HbA1c) between 7% and 9%. - Body mass index = 25 kg/m2 Exclusion Criteria: - Pregnant or nursing women. - Type 1 diabetes mellitus. - Liver disease (alanine aminotransferase > 3 upper normal limit). - Kidney disease (estimated glomerular filtration rate < 60 ml/min/1.73 m2). - Inflammatory bowel diseases. - History of allergy and/or adverse reactions to the drugs used in the study. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of Medicine, Menoufia University | Shibin Al Kawm | Menoufia |
| Egypt | Faculty of medicine, Tanta University | Tanta | El-Gharbia |
| Lead Sponsor | Collaborator |
|---|---|
| Tanta University | Menoufia University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glycemic control | Fasting blood glucose and glycated hemoglobin | 12 weeks | |
| Secondary | Insulin resistance | fasting insulin level with HOMA-IR calculation | 12 weeks | |
| Secondary | Lipid profile | Serum levels of total cholesterol, LDL, HDL, and triglycerides | 12 weeks | |
| Secondary | Serum levels of A-kinase anchoring protein 1 | 12 weeks | ||
| Secondary | Serum levels of asprosin | 12 weeks |
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