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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristiano Fava, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01181830
First received: August 12, 2010
Last updated: October 15, 2013
Last verified: October 2013

August 12, 2010
October 15, 2013
February 2010
December 2012   (final data collection date for primary outcome measure)
Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Blood pressure measured in the lying and standing position (average of three measurements);
Same as current
Complete list of historical versions of study NCT01181830 on ClinicalTrials.gov Archive Site
  • other features of metabolic syndrome [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    especially plasma lipids and HOMA index
  • endothelial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    endothelial function as measured non-invasively by ultrasound using the "Flow Mediated Dilatation" (FMD) technique
  • arterial stiffness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    systemic and local arterial stiffness measured by digital photoplethysmography and by carotid ultrasound
  • Inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Markers of inflammation such as C reactive protein
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Family History of Metabolic Syndrome
  • Family History of Diabetes
  • Drug: magnesium pidolate
    administration of 8.1 mmol bid of magnesium pidolate
  • Drug: placebo
    administration of 8.1 mmol bid of placebo
  • Active Comparator: magnesium pidolate
    administration of 8.1 mmol bid of magnesium pidolate for 8 weeks
    Intervention: Drug: magnesium pidolate
  • Placebo Comparator: placebo
    administration of 8.1 mmol bid of placebo for 8 weeks
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01181830
CF_Mg_fam_MetS
No
Cristiano Fava, Universita di Verona
Universita di Verona
Not Provided
Principal Investigator: Pietro Delva, MD Universita of Verona
Principal Investigator: Cristiano Fava, MD, PhD Universita of Verona
Universita di Verona
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP