Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

Obesity Clinical Trial

Official title:

Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966912
• Other study ID #: 442702
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 2019

Study information

• Verified date: February 2023
• Source: Providence VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Obesity

Intervention

Dietary Supplement:
• 400 mg of Magnesium Oxide twice daily for 24 weeks

Other:
• Open label (none)

Locations

Country	Name	City	State
United States	Providence VA Medical Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Providence VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular mass (by cardiac MRI)		24 weeks
Primary	Left ventricular myocardial triglyceride content (by cardiac MRI)		24 weeks
Primary	Left ventricular extracellular volume fraction (by cardiac MRI)		24 weeks
Secondary	Systolic blood pressure		24 weeks
Secondary	Aortic pulse wave velocity (by cardiac MRI)		24 weeks