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临床试验/NCT04387019
NCT04387019已完成不适用

Relation Between Plasma Vitamin K2 and Glycemic Control and Metabolic Parameters in Type 2 Diabetic Patients.

Cairo University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
plasma vitamin k2 level

研究概览

简要总结

Background and Rationale:

The agents inducing type 2 diabetes are yet to be clarified. Current studies show that several genetic and environmental parameters are associated with type 2 diabetes . Vitamin K is emerging as an important micronutrient for its beneficial role in improving insulin sensitivity and glucose metabolism and reducing the risk of type 2 diabetes (T2 D) . Studies demonstrated the lowest prevalence of Metabolic syndrome and its five components among individuals with the highest phylloquinone intake.

Objectives : The aim of our study was to evaluate the relation between plasma vitamin K2 and uncontrolled Type 2 diabetic patients.

详细描述

The frequency of diabetes mellitus is increasing globally and it is expected that this latent disorder will affect 300 million by 2025. Type 2 diabetes mellitus (T2DM) is a metabolic and chronic disease characterized by hyperglycemia representing the major cause of various micro and macrovascular complications

The agents inducing type 2 diabetes are yet to be clarified; however, it has been suggested that diabetes is an immune-dependent disease . Current studies show that several genetic and environmental parameters are associated with type 2 diabetes .

Vitamin K is a fat soluble vitamin . Two vitamin K- dependent-proteins, osteocalcin and matrix gamma carboxy glutamate (Gla ) protein, present in skeletal and vascular system , vitamin K exists mainly in two biologically active forms: vitamin K1 (also known as phylloquinone) and vitamin K2 (also known as menaquinone) .

According to current studies, vitamin K2 has a wider range of effects besides coagulation and functioning as a cofactor for γ--glutamate carboxylase (GGCX ) . The effect on bone is to prevent and treat osteoporosis and the effect on the cardiovascular system is to prevent and treat vascular calcification.

study by Sogabe N et al ., reported an important role of vitamin K in the regulation of dyslipidemia and vitamin K2 treatment delayed the progression of atherosclerotic plaque formation, intima-thickening, and pulmonary atherosclerosis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 20 to 65 years old with controlled and uncontrolled DM .

排除标准

  • • Subjects with hepatic , gastrointestinal or cardiovascular disease
  • Subjects with osteoporosis.
  • Subjects using vitamin supplements containing vitamin K.
  • Subjects using oral anticoagulants.

结局指标

主要结局

plasma vitamin k2 level

时间窗: 3 months

Plasma vitamin K2 level as ng/ml in type 2 diabetes patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Youssry Helmy

lecturer of internal medicine .

Cairo University

研究点 (1)

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