- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00603499
Magnesium and Metabolic Syndrome
Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Durango, Mexico, 34067
- Biomedical Research Unit
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
Subjects in the control group received inert placebo once per day during 4 months
|
Active Comparator: 1
Magnesium chloride
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in the systolic and diastolic blood pressures
Time Frame: 2 y
|
2 y
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average increase of serum magnesium levels Changes in lipid profile
Time Frame: 2 y
|
2 y
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martha Rodriguez-Moran, MD, MSc, PhD, Instituto Mexicano del Seguro Social
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000-161-0027
- IMSS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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