Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome

Conditions
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Family History of Metabolic Syndrome, Family History of Diabetes

Intervention / Treatment
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* Drug: magnesium pidolate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive family history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: magnesium pidolate<br>administration of 8.1 mmol bid of magnesium pidolate for 8 weeks | Drug: magnesium pidolate<br>* administration of 8.1 mmol bid of magnesium pidolate<br>|
| Placebo Comparator: placebo<br>administration of 8.1 mmol bid of placebo for 8 weeks | Drug: placebo<br>* administration of 8.1 mmol bid of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure measured in the lying and standing position (average of three measurements); | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other features of metabolic syndrome | especially plasma lipids and HOMA index | 8 weeks | 
| endothelial function | endothelial function as measured non-invasively by ultrasound using the Flow Mediated Dilatation (FMD) technique | 8 weeks | 
| arterial stiffness | systemic and local arterial stiffness measured by digital photoplethysmography and by carotid ultrasound | 8 weeks | 
| Inflammation | Markers of inflammation such as C reactive protein | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium, metabolic syndrome, diabetes, family history