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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01181830
Enrollment
14
Registered
2010-08-13
Start date
2010-02-28
Completion date
2012-12-31
Last updated
2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family History of Diabetes, Family History of Metabolic Syndrome

Keywords

magnesium, metabolic syndrome, diabetes, family history

Brief summary

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).

Interventions

administration of 8.1 mmol bid of magnesium pidolate

DRUGplacebo

administration of 8.1 mmol bid of placebo

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure8 weeksBlood pressure measured in the lying and standing position (average of three measurements);

Secondary

MeasureTime frameDescription
other features of metabolic syndrome8 weeksespecially plasma lipids and HOMA index
endothelial function8 weeksendothelial function as measured non-invasively by ultrasound using the Flow Mediated Dilatation (FMD) technique
arterial stiffness8 weekssystemic and local arterial stiffness measured by digital photoplethysmography and by carotid ultrasound
Inflammation8 weeksMarkers of inflammation such as C reactive protein

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026