Magnesium and Metabolic Syndrome

Phase 4

Completed

• Conditions: High Blood Pressure; Hypomagnesemia; Diabetes Mellitus
• Interventions: Dietary Supplement: Magnesium chloride; Other: Placebo

• Registration Number: NCT00603499
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-08
• Study Completion: 2007-11
• Status Verified: 2008-01
• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-16
• Last Update Submitted: 2008-01-16
• Study First Posted: 2008-01-29
• Last Update Posted: 2008-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Magnesium chloride	Magnesium chloride
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Reduction in the systolic and diastolic blood pressures	2 y

Secondary Outcome Measures

Name	Time	Method
Average increase of serum magnesium levels Changes in lipid profile	2 y

Trial Locations

Locations (1)

Biomedical Research Unit; 🇲🇽 Durango, Mexico