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

October 15, 2013 updated by: Cristiano Fava, Universita di Verona

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF_Mg_fam_MetS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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