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

• ClinicalTrials.gov Identifier: NCT01181830
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: October 16, 2013
• Sponsor: Universita di Verona
• Information provided by (Responsible Party): Cristiano Fava, Universita di Verona

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 (Clinical Trial)
• 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: February 2010
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Italy

Azienda Ospedaliera Universitaria Integrata - Division of Internal Medicine C

Verona, VR, Italy, 37134

Sponsors and Collaborators

Universita di Verona

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Cristiano Fava, MD, PhD, Universita di Verona
• ClinicalTrials.gov Identifier: NCT01181830
• Other Study ID Numbers: CF_Mg_fam_MetS
• First Posted: August 13, 2010
• Last Update Posted: October 16, 2013
• Last Verified: October 2013

Keywords provided by Cristiano Fava, Universita di Verona:

magnesium; metabolic syndrome; diabetes; family history

Additional relevant MeSH terms:

Diabetes Mellitus; Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism