Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Nitazoxanide

• Registration Number: NCT06010992
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25
• Study Start: 2023-10-01
• Primary Completion: 2024-10-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Nitazoxanide	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).

Primary Outcome Measures

Name	Time	Method
Glycemic control	12 weeks	Fasting blood glucose and glycated hemoglobin

Secondary Outcome Measures

Name	Time	Method
Serum levels of asprosin	12 weeks
Insulin resistance	12 weeks	fasting insulin level with HOMA-IR calculation
Lipid profile	12 weeks	Serum levels of total cholesterol, LDL, HDL, and triglycerides
Serum levels of A-kinase anchoring protein 1	12 weeks

Trial Locations

Locations (2)

Faculty of medicine, Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt

Faculty of Medicine, Menoufia University; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt