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

Family History of Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181830
• Other study ID #: CF_Mg_fam_MetS
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2010
• Last updated: October 15, 2013
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana del Farmaco (AIFA)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Family History of Diabetes
• Family History of Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• magnesium pidolate
administration of 8.1 mmol bid of magnesium pidolate
• placebo
administration of 8.1 mmol bid of placebo

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Integrata - Division of Internal Medicine C	Verona	VR

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Blood pressure measured in the lying and standing position (average of three measurements);	8 weeks	No
Secondary	other features of metabolic syndrome	especially plasma lipids and HOMA index	8 weeks	No
Secondary	endothelial function	endothelial function as measured non-invasively by ultrasound using the "Flow Mediated Dilatation" (FMD) technique	8 weeks	No
Secondary	arterial stiffness	systemic and local arterial stiffness measured by digital photoplethysmography and by carotid ultrasound	8 weeks	No
Secondary	Inflammation	Markers of inflammation such as C reactive protein	8 weeks	No