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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

January 16, 2008
January 16, 2008
July 2006
August 2007   (final data collection date for primary outcome measure)
Reduction in the systolic and diastolic blood pressures [ Time Frame: 2 y ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Average increase of serum magnesium levels Changes in lipid profile [ Time Frame: 2 y ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Magnesium and Metabolic Syndrome
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • High Blood Pressure
  • Hypomagnesemia
  • 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.
  • Other: Placebo
    Subjects in the control group received inert placebo once per day during 4 months
  • Active Comparator: 1
    Magnesium chloride
    Intervention: Dietary Supplement: Magnesium chloride
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
November 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00603499
2000-161-0027, IMSS
Yes
Fernando Guerrero-Romero, Biomedical Research Unit, Instituto Mexicano del Seguro Social
Instituto Mexicano del Seguro Social
Not Provided
Principal Investigator: Martha Rodriguez-Moran, MD, MSc, PhD Instituto Mexicano del Seguro Social
Instituto Mexicano del Seguro Social
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP