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Magnesium and Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT00603499
First received: January 16, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes Mellitus
High Blood Pressure
Hypomagnesemia
 Dietary Supplement: Magnesium chloride
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • Reduction in the systolic and diastolic blood pressures [ Time Frame: 2 y ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average increase of serum magnesium levels Changes in lipid profile [ Time Frame: 2 y ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: July 2006
Study Completion Date: November 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 16, 2008
Last Updated: January 16, 2008
Health Authority: Mexico: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013