Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Nitazoxanide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>35 Patients with type 2 diabetes receiving treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin). | |
| Experimental: Group 2<br>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). | Drug: Nitazoxanide<br>* Nitazoxanide oral capsules 500 mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Fasting blood glucose and glycated hemoglobin | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 weeks | 
| Serum levels of A-kinase anchoring protein 1 |  | 12 weeks | 
| Serum levels of asprosin |  | 12 weeks |