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

Sponsor

Universita di Verona (Other)

Overall Status

Completed

CT.gov ID

NCT01181830

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Family History of Metabolic Syndrome Family History of Diabetes	Drug: magnesium pidolate Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: magnesium pidolate administration of 8.1 mmol bid of magnesium pidolate for 8 weeks	Drug: magnesium pidolate administration of 8.1 mmol bid of magnesium pidolate
Placebo Comparator: placebo administration of 8.1 mmol bid of placebo for 8 weeks	Drug: placebo administration of 8.1 mmol bid of placebo

Arm

Intervention/Treatment

Active Comparator: magnesium pidolate

administration of 8.1 mmol bid of magnesium pidolate for 8 weeks

Drug: magnesium pidolate

administration of 8.1 mmol bid of magnesium pidolate

Placebo Comparator: placebo

administration of 8.1 mmol bid of placebo for 8 weeks

Drug: placebo

administration of 8.1 mmol bid of placebo

Outcome Measures

Primary Outcome Measures

Blood pressure [8 weeks]
Blood pressure measured in the lying and standing position (average of three measurements);

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.