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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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Metabolic Syndrome X
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016