Family History of Metabolic SyndromePhase 4NCT01181830
Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome
A Phase 4 study testing magnesium pidolate in people with Family History of Metabolic Syndrome and Family History of Diabetes, run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Family History of Metabolic Syndrome, Family History of Diabetes
- What is being tested?
- magnesium pidolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- positive family history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Universitaria Integrata - Division of Internal Medicine C
Verona, VR, 37134
About this study
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.
Read more
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).
- Being tested
- magnesium pidolate, placebo
- Keywords
- magnesium, metabolic syndrome, diabetes, family history
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium pidolateDrug
administration of 8.1 mmol bid of magnesium pidolate
placeboDrug
administration of 8.1 mmol bid of placebo
| Study group | Role | What they receive |
|---|---|---|
| magnesium pidolate | Active comparator | administration of 8.1 mmol bid of magnesium pidolate for 8 weeks Receives: Drug: magnesium pidolate |
| placebo | Placebo comparator | administration of 8.1 mmol bid of placebo for 8 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure measured in the lying and standing position (average of three measurements);
Measured: 8 weeks
Secondary outcomes (4)
other features of metabolic syndrome
especially plasma lipids and HOMA index
Measured: 8 weeks
endothelial function
endothelial function as measured non-invasively by ultrasound using the "Flow Mediated Dilatation" (FMD) technique
Measured: 8 weeks
arterial stiffness
systemic and local arterial stiffness measured by digital photoplethysmography and by carotid ultrasound
Measured: 8 weeks
Inflammation
Markers of inflammation such as C reactive protein
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family History of Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiano Fava, Universita di Verona
- Investigators
- Pietro Delva, MD, Principal investigator, Universita of VeronaCristiano Fava, MD, PhD, Principal investigator, Universita of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181830
- Sponsor's protocol ID
- CF_Mg_fam_MetS
- Status last verified
- Oct 2013
- First submitted
- 12 Aug 2010
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24984823
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01181830
- Acronym / sponsor ID
- CF_Mg_fam_MetS
- Keywords
- magnesium, metabolic syndrome, diabetes, family history
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium pidolate | Active comparator | Drug: magnesium pidolateadministration of 8.1 mmol bid of magnesium pidolate for 8 weeks |
| placebo | Placebo comparator | Drug: placeboadministration of 8.1 mmol bid of placebo for 8 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- positive family history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium pidolateadministration of 8.1 mmol bid of magnesium pidolate | Drug | magnesium pidolate |
| placeboadministration of 8.1 mmol bid of placebo | Drug | placebo |
Primary outcome
Blood pressure
Time frame: 8 weeks
Blood pressure measured in the lying and standing position (average of three measurements);
4 secondary outcomes
other features of metabolic syndrome
Time frame: 8 weeks
endothelial function
Time frame: 8 weeks
arterial stiffness
Time frame: 8 weeks
Inflammation
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Derived from this study: PubMed 24984823Cosaro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Delva, MD principal investigator
Universita of Verona
Cristiano Fava, MD, PhD principal investigator
Universita of Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing magnesium pidolate in people with Family History of Metabolic Syndrome and Family History of Diabetes, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01181830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.