A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus
概览
- 阶段
- 2 期
- 干预措施
- Nitazoxanide
- 疾病 / 适应症
- Diabetes Mellitus, Type 2
- 发起方
- Tanta University
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Glycemic control
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
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.
研究者
入排标准
入选标准
- •Glycated hemoglobin (HbA1c) between 7% and 9%.
- •Body mass index ≥ 25 kg/m2
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Nitazoxanide
结局指标
主要结局
Glycemic control
时间窗: 12 weeks
Fasting blood glucose and glycated hemoglobin
次要结局
- Serum levels of asprosin(12 weeks)
- Insulin resistance(12 weeks)
- Lipid profile(12 weeks)
- Serum levels of A-kinase anchoring protein 1(12 weeks)