Magnesium and Metabolic Syndrome - Full Text View

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:

MedlinePlus related topics: Diabetes High Blood Pressure Metabolic Syndrome

Drug Information available for: Magnesium Chlorine Magnesium chloride

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

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

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

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

ClinicalTrials.gov processed this record on February 26, 2015