A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Glycemic control
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (Drug)
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)
研究者
Eman Ghonaim
Assistant lecturer
Tanta University