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Completed

NCT Number: NCT02966912

Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence VA Medical Center

Providence, Rhode Island, 02908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

400 mg of Magnesium Oxide twice daily for 24 weeks

Dietary Supplement

Open label (none)

Other

Primary outcomes

  1. Left ventricular mass (by cardiac MRI)

    Time frame: 24 weeks

  2. Left ventricular myocardial triglyceride content (by cardiac MRI)

    Time frame: 24 weeks

  3. Left ventricular extracellular volume fraction (by cardiac MRI)

    Time frame: 24 weeks

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 24 weeks

  2. Aortic pulse wave velocity (by cardiac MRI)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Providence VA Medical Center

Fed

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2016
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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