Magnesium and Metabolic Syndrome

NCT00603499 | Completed Phase 4 DMC

• 2 other identifiers: 2000-161-0027IMSS
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus; High Blood Pressure; Hypomagnesemia

Keywords

Diabetes; Hypertension; Hypomagnesemia

Outcome Measures

Primary Outcomes (1)

• Reduction in the systolic and diastolic blood pressures

  2 y

Secondary Outcomes (1)

• Average increase of serum magnesium levels Changes in lipid profile

  2 y

Study Arms (2)

1

ACTIVE COMPARATOR

Magnesium chloride

Dietary Supplement: Magnesium chloride

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Magnesium chloride DIETARY_SUPPLEMENT

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.

1

Placebo OTHER

Subjects in the control group received inert placebo once per day during 4 months

2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Decreased serum magnesium levels
• Uncomplicated hypertension
• and 75 years of age
• Men and Women

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Biomedical Research Unit

Durango, Durango, 34067, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Interventions

Magnesium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Magnesium Compounds

Study Officials

• Martha Rodriguez-Moran, MD, MSc, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 29, 2008
• Study Start: July 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 29, 2008

Record last verified: 2008-01

Locations

ME (1)