Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Magnesium

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

Group Type EXPERIMENTAL

400 mg of Magnesium Oxide twice daily for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Comparator

20 participants will receive no treatment

Group Type ACTIVE_COMPARATOR

Open label (none)

Intervention Type OTHER

Interventions

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400 mg of Magnesium Oxide twice daily for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Open label (none)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No