Family History of Diabetes Clinical Trial
Official title:
Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment