A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Glycemic control
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group 2
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).
Intervention: Nitazoxanide (Drug)
Outcomes
Primary Outcomes
Glycemic control
Time Frame: 12 weeks
Fasting blood glucose and glycated hemoglobin
Secondary Outcomes
- Serum levels of asprosin(12 weeks)
- Insulin resistance(12 weeks)
- Lipid profile(12 weeks)
- Serum levels of A-kinase anchoring protein 1(12 weeks)
Investigators
Eman Ghonaim
Assistant lecturer
Tanta University