Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Magnesium is the second most abundant ion in human cells and plays fundamental roles in several enzymatic reactions: it is involved in ATP production, in the phosphorylation of proteins, in glucose metabolism and in the contraction of cytoskeleton.
Several epidemiological studies demonstrated that low dietary magnesium intake is inversely associated with diabetes mellitus, hypertension and metabolic syndrome.
Magnesium could be related to important haemodynamic and metabolic anomalies: at vascular level it acts as an antagonist of calcium, especially in vascular smooth muscle cells, thus its deficit could enhance vascular contraction; with regard to glucose metabolism, magnesium is involved in the physiopathological mechanism of insulin resistance, through a reduction in cellular uptake of glucose. This condition and the subsequent compensatory hyperinsulinemia can ultimately lead to increased synthesis of proinflammatory cytokines and to endothelial dysfunction. Thus, magnesium depletion and subsequent alterations can increase the risk of developing vascular disease such as atherosclerosis and has been associated with cardiovascular events.
Several clinical trials have explored the possible beneficial effect of magnesium supplementation on blood pressure, plasma lipids and insulin resistance but the results are often contradictory. One of the possibilities for these unclear results could be that in some of them the interventions started too late when haemodynamic and metabolic changes are more difficult to revert.
The investigators hypothesis is that magnesium supplementation in a population at increased genetic risk of developing metabolic syndrome but without it could improve blood pressure and the other metabolic syndrome related components.
Thus, the aim of the present study is to evaluate the effect of oral supplementation of magnesium (16.2 mmol/day of magnesium pidolate) on metabolic syndrome's components in a sample of 15 subjects who are at increased risk of developing metabolic syndrome since have a positive familiar history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •positive family history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).
排除标准
- •any therapy related to metabolic syndrome (that is antihypertensive, anti diabetic, antilipemic drugs);
- •age < 18 years or >50 years;
- •previously diagnosed hypertension or immediate need for antihypertensive therapy (BP≥160/100);
- •diabetes mellitus (ADA criteria);
- •obesity (BMI>30Kg/m2);
- •Continuative use of NSAIDs, magnesium or vitamin supplements;
- •Hypermagnesaemia;
- •Previous cardio- or cerebrovascular events;
- •chronic kidney or liver or inflammatory or neoplastic disease;
- •gastrointestinal dysfunction with hypomotility;
- •active smoke (>5 cigarettes per day);
- •Impossibility to give informed consent.
研究组 & 干预措施
magnesium pidolate
administration of 8.1 mmol bid of magnesium pidolate for 8 weeks
干预措施: magnesium pidolate (Drug)
placebo
administration of 8.1 mmol bid of placebo for 8 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Blood pressure
时间窗: 8 weeks
Blood pressure measured in the lying and standing position (average of three measurements);
次要结局
- other features of metabolic syndrome(8 weeks)
- endothelial function(8 weeks)
- Inflammation(8 weeks)
- arterial stiffness(8 weeks)
研究者
Cristiano Fava
MD, PhD
Universita di Verona