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Magnesium and Metabolic Syndrome

Primary Purpose

Diabetes Mellitus, High Blood Pressure, Hypomagnesemia

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Magnesium chloride
Placebo
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes, Hypertension, Hypomagnesemia

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Biomedical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Magnesium chloride

Placebo

Outcomes

Primary Outcome Measures

Reduction in the systolic and diastolic blood pressures

Secondary Outcome Measures

Average increase of serum magnesium levels Changes in lipid profile

Full Information

First Posted
January 16, 2008
Last Updated
January 16, 2008
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT00603499
Brief Title
Magnesium and Metabolic Syndrome
Official Title
Hypomagnesemia as a Risk Factor for Development of Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Mexicano del Seguro Social

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, High Blood Pressure, Hypomagnesemia
Keywords
Diabetes, Hypertension, Hypomagnesemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Magnesium chloride
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium chloride
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects in the control group received inert placebo once per day during 4 months
Primary Outcome Measure Information:
Title
Reduction in the systolic and diastolic blood pressures
Time Frame
2 y
Secondary Outcome Measure Information:
Title
Average increase of serum magnesium levels Changes in lipid profile
Time Frame
2 y

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Rodriguez-Moran, MD, MSc, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biomedical Research Unit
City
Durango
ZIP/Postal Code
34067
Country
Mexico

12. IPD Sharing Statement

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Magnesium and Metabolic Syndrome

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