Magnesium and Metabolic Syndrome

Diabetes Mellitus Clinical Trial

Official title:

Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603499
• Other study ID #: 2000-161-0027
• Secondary ID: IMSS
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2008
• Last updated: January 16, 2008
• Start date: July 2006
• Est. completion date: November 2007

Study information

• Verified date: January 2008
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• High Blood Pressure
• Hypertension
• Hypomagnesemia
• Metabolic Syndrome X

Intervention

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

Locations

Country	Name	City	State
Mexico	Biomedical Research Unit	Durango

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the systolic and diastolic blood pressures		2 y	Yes
Secondary	Average increase of serum magnesium levels Changes in lipid profile		2 y	Yes