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

NCT01181830 | Completed Phase 4

• 1 other identifier: CF_Mg_fam_MetS
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Family History of Metabolic Syndrome; Family History of Diabetes

Keywords

magnesium; metabolic syndrome; diabetes; family history

Outcome Measures

Primary Outcomes (1)

• Blood pressure

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

  8 weeks

Secondary Outcomes (4)

• other features of metabolic syndrome

  8 weeks

• endothelial function

  8 weeks

• arterial stiffness

  8 weeks

• Inflammation

  8 weeks

Study Arms (2)

magnesium pidolate

ACTIVE COMPARATOR

administration of 8.1 mmol bid of magnesium pidolate for 8 weeks

Drug: magnesium pidolate

placebo

PLACEBO COMPARATOR

administration of 8.1 mmol bid of placebo for 8 weeks

Drug: placebo

Interventions

magnesium pidolate DRUG

administration of 8.1 mmol bid of magnesium pidolate

magnesium pidolate

placebo DRUG

administration of 8.1 mmol bid of placebo

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• positive family history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata - Division of Internal Medicine C

Verona, VR, 37134, Italy

Location

Related Publications (1)

• 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.

  PMID: 24984823 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus

Interventions

Pyrrolidonecarboxylic Acid

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Imino Acids; Amino Acids, Cyclic

Study Officials

• Pietro Delva, MD

  Universita of Verona

  PRINCIPAL INVESTIGATOR

• Cristiano Fava, MD, PhD

  Universita of Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

IT (1)