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).

Study Overview

• Status: Completed
• Conditions: Family History of Metabolic Syndrome; Family History of Diabetes
• Intervention / Treatment: Drug: magnesium pidolate; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • VR
    • Verona, VR, Italy, 37134
      • Azienda Ospedaliera Universitaria Integrata - Division of Internal Medicine C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Pietro Delva, MD, Universita of Verona; Principal Investigator: Cristiano Fava, MD, PhD, Universita of Verona

Publications and helpful links

General Publications

• Cosaro E, Bonafini S, Montagnana M, Danese E, Trettene MS, Minuz P, Delva P, Fava C. Effects of magnesium supplements on blood pressure, endothelial function and metabolic parameters in healthy young men with a family history of metabolic syndrome. Nutr Metab Cardiovasc Dis. 2014 Nov;24(11):1213-20. doi: 10.1016/j.numecd.2014.05.010. Epub 2014 May 28.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: diabetes; metabolic syndrome; magnesium; family history
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: CF_Mg_fam_MetS