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临床试验/NCT03002545
NCT03002545已完成不适用

Effects of a 12-week Supplementation With 400 mg Magnesium From Magnesium Citrate on Blood Sugar, Blood Pressure and Expression of Magnesium-sensitive Genes in Patients With Type II Diabetes

Protina Pharmazeutische GmbH2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
questionnaire SF-36

研究概览

简要总结

This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium from organic magnesium citrate affects blood glucose control and insulin resistance within patients with type 2 diabetes (HbA1c> 6%) and how the expression of certain Mg-sensitive transporting genes is affected .

详细描述

The examinations are carried out in 50 subjects aged 20-80 years with existing type 2 diabetes (HbA1c> 6%). The target parameters are determined in the blood. Blood sampling takes place at confinement, after 6 weeks and at the end of the study (week 12). In addition, blood pressure is determined and general health condition of each subject is recorded by a standardized questionnaire (SF-36).

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type II Diabetics (HbA1c > 6%)

排除标准

  • pregnancy, lactation
  • persons with severe renal impairment (glomerular filtration rate <30 ml / min)
  • use of insulin, oral antidiabetic drugs, diuretics, antacids or proton pump inhibitors within 4 weeks prior to study start and during the study
  • intake of vitamin supplements, dietary supplements, mineral products or possibly enriched foods containing Magnesium within 4 weeks before study start and during the study

研究组 & 干预措施

Placebo

Placebo Comparator

identically tasting and looking Placebo

干预措施: Placebo (Dietary Supplement)

Magnesium

Active Comparator

Supplementation with 400 mg Magnesium from Magnesium citrate once daily

干预措施: Magnesium citrate (Dietary Supplement)

结局指标

主要结局

questionnaire SF-36

时间窗: 12 weeks

questionnaire is used to assess the physiological health Status of patients

blood sampling

时间窗: 12 weeks

measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression

blood pressure measurement

时间窗: 12 weeks

measurement of blood pressure

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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