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Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
400 mg of Magnesium Oxide twice daily for 24 weeks
Open label (none)
Sponsored by
Providence VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Body mass index greater than 30 kg/m2

Exclusion Criteria:

  1. History of hospitalization for heart failure (systolic or diastolic);
  2. Unstable angina or prior myocardial infarction;
  3. LV ejection fraction <50% on imaging study;
  4. Valvular heart disease (stenosis or insufficiency) greater than moderate degree;
  5. Renal dysfunction, serum creatinine >2.5 mg/dL or estimated creatinine clearance <30 mL/min/1.73 m2 (30),
  6. Pregnant women or actively breastfeeding women
  7. History of drug supplementation within the last 6 months in which more than 50 miliequivalents per day of supplemental magnesium is contained

Sites / Locations

  • Providence VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnesium

Comparator

Arm Description

20 participants will be treated with 400 mg of Magnesium Oxide twice daily

20 participants will receive no treatment

Outcomes

Primary Outcome Measures

Left ventricular mass (by cardiac MRI)
Left ventricular myocardial triglyceride content (by cardiac MRI)
Left ventricular extracellular volume fraction (by cardiac MRI)

Secondary Outcome Measures

Systolic blood pressure
Aortic pulse wave velocity (by cardiac MRI)

Full Information

First Posted
November 15, 2016
Last Updated
February 22, 2023
Sponsor
Providence VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02966912
Brief Title
Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity
Official Title
Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Providence VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Specifically, in a randomized open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.
Detailed Description
The investigators propose a 24-week therapeutic trial involving 40 participants with obesity from the Providence VA Medical Center without clinical heart failure. 20 participants will be treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium
Arm Type
Experimental
Arm Description
20 participants will be treated with 400 mg of Magnesium Oxide twice daily
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
20 participants will receive no treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
400 mg of Magnesium Oxide twice daily for 24 weeks
Intervention Type
Other
Intervention Name(s)
Open label (none)
Primary Outcome Measure Information:
Title
Left ventricular mass (by cardiac MRI)
Time Frame
24 weeks
Title
Left ventricular myocardial triglyceride content (by cardiac MRI)
Time Frame
24 weeks
Title
Left ventricular extracellular volume fraction (by cardiac MRI)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Time Frame
24 weeks
Title
Aortic pulse wave velocity (by cardiac MRI)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index greater than 30 kg/m2 Exclusion Criteria: History of hospitalization for heart failure (systolic or diastolic); Unstable angina or prior myocardial infarction; LV ejection fraction <50% on imaging study; Valvular heart disease (stenosis or insufficiency) greater than moderate degree; Renal dysfunction, serum creatinine >2.5 mg/dL or estimated creatinine clearance <30 mL/min/1.73 m2 (30), Pregnant women or actively breastfeeding women History of drug supplementation within the last 6 months in which more than 50 miliequivalents per day of supplemental magnesium is contained
Facility Information:
Facility Name
Providence VA Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

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