Magnesium and Metabolic Syndrome

January 16, 2008 updated by: Instituto Mexicano del Seguro Social

Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

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

  • Mexico
      • Durango, Mexico, 34067
        • Biomedical Research Unit

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

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Other: Placebo
Subjects in the control group received inert placebo once per day during 4 months
Active Comparator: 1
Magnesium chloride
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in the systolic and diastolic blood pressures
Time Frame: 2 y
2 y

Secondary Outcome Measures

Outcome Measure
Time Frame
Average increase of serum magnesium levels Changes in lipid profile
Time Frame: 2 y
2 y

Collaborators and Investigators

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

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Martha Rodriguez-Moran, MD, MSc, PhD, Instituto Mexicano del Seguro Social

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

July 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 16, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 16, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000-161-0027
  • IMSS

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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