NCT04285450已完成不适用
The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Homeostasis model assessment of insulin resistance (HOMA-IR)
研究概览
简要总结
The aim of this study is to examine the possible clinical effects associated with vitamin K supplementation on the glycemic control, insulin sensitivity and lipid profile of type II diabetic patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 21-65 years old diagnosed with Type II diabetes.
- •Fasting blood glucose concentration ≥ 126 mg/dL .
- •Normal liver Function tests defined as ALT levels up to 33 U/L for males and up to 25 U/L for females, Albumin levels ≥ 3.5 g/dL, Bilirubin up to 1.1 mg/dL .
- •Normal clotting function defined as defined by INR.
- •Normal kidney function defined as serum creatinine values up to 1.3 mg/dL.
排除标准
- •Type I diabetic patients.
- •Use of supplements with potential effect on vitamin K level namely supplements containing vitamin K, co-enzyme Q10 or vitamin E > 400 IU .
- •Patients requiring anti-coagulant therapy including patients with prosthetic valves, mitral tissues, DVT, PE, atrial fibrillation and valvular heart disease.
- •Patient with history of coagulation, MI, stroke and embolization.
- •Pregnant or breast feeding women.
- •Being on hormonal therapy or receiving contraceptive pills.
- •Patients treated with glucocorticoids, thiazide diuretics, and atypical antipsychotics.
- •Patients on cholestyramine, antibiotics and coumarins.
- •Patients on lipid lowering agents.
- •Known intestinal malabsorption syndrome, cholestasis or steatorrhea.
结局指标
主要结局
Homeostasis model assessment of insulin resistance (HOMA-IR)
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
Amani Mohamed
Assistant Lecturer
Cairo University
研究点 (2)
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