Magnesium and Metabolic Syndrome

NCT ID: NCT00603499

Last Updated: 2008-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-11-30

Brief Summary

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Objective : to test the BP lowering-effect of oral magnesium supplementation, as magnesium chloride (MgCl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic subjects with decreased serum magnesium levels Design : Randomised double blind placebo controlled trial. Setting : Outpatients with type 2 diabetes from Durango, city in northern Mexico Subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum magnesium deficiency and uncomplicated hypertension.

Interventions : During 4 months the intervention group received 2.5 gr of magnesium chloride (50 ml of a solution containing 50 gr of MgCl2 by 1000 ml of solution ). Controls received inert placebo.

Main outcome measure: Change in blood pressure. Increase of serum magnesium Secondary outcomes measures: Changes in lipid profile

Detailed Description

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Conditions

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Diabetes Mellitus High Blood Pressure Hypomagnesemia

Keywords

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Diabetes Hypertension Hypomagnesemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Magnesium chloride

Group Type ACTIVE_COMPARATOR

Magnesium chloride

Intervention Type DIETARY_SUPPLEMENT

Subjects in the intervention group received 2.5 gr of MgCl2 daily during 4 months, from a solution solution containing 50 gr of MgCl2 by 1000 ml.

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subjects in the control group received inert placebo once per day during 4 months

Interventions

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Magnesium chloride

Subjects in the intervention group received 2.5 gr of MgCl2 daily during 4 months, from a solution solution containing 50 gr of MgCl2 by 1000 ml.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Subjects in the control group received inert placebo once per day during 4 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Decreased serum magnesium levels
* Uncomplicated hypertension
* 40 and 75 years of age
* Men and Women

Exclusion Criteria

* Chronic diarrhea
* Alcohol intake (equal or more than 30 g per day)
* Use of diuretics and/or calcium antagonists drugs
* Previous oral magnesium supplementation
* Ischemic diseases; AND
* Reduced renal function
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Biomedical Research Unit, Instituto Mexicano del Seguro Social

Principal Investigators

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Martha Rodriguez-Moran, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

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Biomedical Research Unit

Durango, Durango, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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IMSS

Identifier Type: -

Identifier Source: secondary_id

2000-161-0027

Identifier Type: -

Identifier Source: org_study_id