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Magnesium and Metabolic Syndrome
This study has been completed.
Sponsor:
Instituto Mexicano del Seguro Social
Information provided by:
Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT00603499
First received: January 16, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
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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 Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
| Official Title: | Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome |
Resource links provided by NLM:
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 ]
Secondary Outcome Measures:
- Average increase of serum magnesium levels Changes in lipid profile [ Time Frame: 2 y ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00603499
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
| 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 |
Keywords provided by Instituto Mexicano del Seguro Social:
|
Diabetes Hypertension Hypomagnesemia |
Additional relevant MeSH terms:
|
Diabetes Mellitus Metabolic Syndrome X Hypertension Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Insulin Resistance Hyperinsulinism Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 21, 2017