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
  Purpose

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 Intervention Phase
Family History of Metabolic Syndrome
Family History of Diabetes
Drug: magnesium pidolate
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Blood pressure measured in the lying and standing position (average of three measurements);


Secondary Outcome Measures:
  • 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


Enrollment: 14
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01181830

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

No publications provided

Responsible Party: Cristiano Fava, MD, PhD, Universita di Verona
ClinicalTrials.gov Identifier: NCT01181830     History of Changes
Other Study ID Numbers: CF_Mg_fam_MetS
Study First Received: August 12, 2010
Last Updated: October 15, 2013
Health Authority: Italy: Agenzia Italiana del Farmaco (AIFA)

Keywords provided by Universita di Verona:
magnesium
metabolic syndrome
diabetes
family history

Additional relevant MeSH terms:
Metabolic Syndrome X
Diabetes Mellitus
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014