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Magnesium and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00603499
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : January 29, 2008
Sponsor:
Information provided by:
Instituto Mexicano del Seguro Social

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus High Blood Pressure Hypomagnesemia Dietary Supplement: Magnesium chloride Other: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome
Study Start Date : July 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : November 2007

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Arms and Interventions
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Arm Intervention/treatment
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.
Placebo Comparator: 2
Placebo
 Other: Placebo
Subjects in the control group received inert placebo once per day during 4 months


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in the systolic and diastolic blood pressures [ Time Frame: 2 y ]

Secondary Outcome Measures :
  1. Average increase of serum magnesium levels Changes in lipid profile [ Time Frame: 2 y ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603499


Locations
Mexico
Biomedical Research Unit
Durango, Mexico, 34067
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Martha Rodriguez-Moran, MD, MSc, PhD Instituto Mexicano del Seguro Social
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Fernando Guerrero-Romero, Biomedical Research Unit, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT00603499     History of Changes
Other Study ID Numbers: 2000-161-0027
IMSS
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: January 2008

Keywords provided by Instituto Mexicano del Seguro Social:
Diabetes
Hypertension
Hypomagnesemia

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Vascular Diseases
Cardiovascular Diseases