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| Sponsored by: |
Instituto Mexicano del Seguro Social |
|---|---|
| Information provided by: | Instituto Mexicano del Seguro Social |
| ClinicalTrials.gov Identifier: | NCT00603499 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome |
| 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 |
|---|---|
|
1: Active Comparator
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.
|
|
2: Placebo Comparator
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Mexico | |
| Biomedical Research Unit | |
| Durango, Mexico, 34067 | |
| Principal Investigator: | Martha Rodriguez-Moran, MD, MSc, PhD | Instituto Mexicano del Seguro Social |
More Information
| Responsible Party: | Biomedical Research Unit, Instituto Mexicano del Seguro Social ( Fernando Guerrero-Romero ) |
| Study ID Numbers: | 2000-161-0027, IMSS |
| Study First Received: | January 16, 2008 |
| Last Updated: | January 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00603499 |
| Health Authority: | Mexico: Ethics Committee |
|
Diabetes Hypertension Hypomagnesemia |
|
Metabolic Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypertension |
|
Cardiovascular Diseases |
