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

Primary Purpose

Family History of Metabolic Syndrome, Family History of Diabetes

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
magnesium pidolate
placebo
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Family History of Metabolic Syndrome focused on measuring magnesium, metabolic syndrome, diabetes, family history

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Azienda Ospedaliera Universitaria Integrata - Division of Internal Medicine C

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

magnesium pidolate

placebo

Arm Description

administration of 8.1 mmol bid of magnesium pidolate for 8 weeks

administration of 8.1 mmol bid of placebo for 8 weeks

Outcomes

Primary Outcome Measures

Blood pressure
Blood pressure measured in the lying and standing position (average of three measurements);

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2010
Last Updated
October 15, 2013
Sponsor
Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT01181830
Brief Title
Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome
Official Title
Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family History of Metabolic Syndrome, Family History of Diabetes
Keywords
magnesium, metabolic syndrome, diabetes, family history

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
magnesium pidolate
Arm Type
Active Comparator
Arm Description
administration of 8.1 mmol bid of magnesium pidolate for 8 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
administration of 8.1 mmol bid of placebo for 8 weeks
Intervention Type
Drug
Intervention Name(s)
magnesium pidolate
Intervention Description
administration of 8.1 mmol bid of magnesium pidolate
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
administration of 8.1 mmol bid of placebo
Primary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure measured in the lying and standing position (average of three measurements);
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
other features of metabolic syndrome
Description
especially plasma lipids and HOMA index
Time Frame
8 weeks
Title
endothelial function
Description
endothelial function as measured non-invasively by ultrasound using the "Flow Mediated Dilatation" (FMD) technique
Time Frame
8 weeks
Title
arterial stiffness
Description
systemic and local arterial stiffness measured by digital photoplethysmography and by carotid ultrasound
Time Frame
8 weeks
Title
Inflammation
Description
Markers of inflammation such as C reactive protein
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro Delva, MD
Organizational Affiliation
Universita of Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristiano Fava, MD, PhD
Organizational Affiliation
Universita of Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Universitaria Integrata - Division of Internal Medicine C
City
Verona
State/Province
VR
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24984823
Citation
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.
Results Reference
derived

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

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