<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02966912</url>
  </required_header>
  <id_info>
    <org_study_id>442702</org_study_id>
    <nct_id>NCT02966912</nct_id>
  </id_info>
  <brief_title>Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity</brief_title>
  <official_title>Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Providence VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Providence VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate whether nutritional supplementation with&#xD;
      magnesium can improve cardiovascular structure and function in participants with obesity -&#xD;
      with a long-term goal of preventing clinical heart failure. Specifically, in a randomized&#xD;
      open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus&#xD;
      no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a 24-week therapeutic trial involving 40 participants with obesity&#xD;
      from the Providence VA Medical Center without clinical heart failure. 20 participants will be&#xD;
      treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no&#xD;
      treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV&#xD;
      structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular&#xD;
      health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">March 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Left ventricular mass (by cardiac MRI)</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Left ventricular myocardial triglyceride content (by cardiac MRI)</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Left ventricular extracellular volume fraction (by cardiac MRI)</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aortic pulse wave velocity (by cardiac MRI)</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Magnesium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 participants will be treated with 400 mg of Magnesium Oxide twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 participants will receive no treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>400 mg of Magnesium Oxide twice daily for 24 weeks</intervention_name>
    <arm_group_label>Magnesium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Open label (none)</intervention_name>
    <arm_group_label>Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Body mass index greater than 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of hospitalization for heart failure (systolic or diastolic);&#xD;
&#xD;
          2. Unstable angina or prior myocardial infarction;&#xD;
&#xD;
          3. LV ejection fraction &lt;50% on imaging study;&#xD;
&#xD;
          4. Valvular heart disease (stenosis or insufficiency) greater than moderate degree;&#xD;
&#xD;
          5. Renal dysfunction, serum creatinine &gt;2.5 mg/dL or estimated creatinine clearance &lt;30&#xD;
             mL/min/1.73 m2 (30),&#xD;
&#xD;
          6. Pregnant women or actively breastfeeding women&#xD;
&#xD;
          7. History of drug supplementation within the last 6 months in which more than 50&#xD;
             miliequivalents per day of supplemental magnesium is contained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Providence VA Medical Center</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Providence VA Medical Center</investigator_affiliation>
    <investigator_full_name>Wen-Chih Wu</investigator_full_name>
    <investigator_title>Chief of Medicine at the PVAMC and Professor of Medicine at Brown University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Oxide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02966912
org study id: 442702
nct id: NCT02966912
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Left ventricular mass (by cardiac MRI)
time frame: 24 weeks
measure: Left ventricular myocardial triglyceride content (by cardiac MRI)
time frame: 24 weeks
measure: Left ventricular extracellular volume fraction (by cardiac MRI)
time frame: 24 weeks
measure: Systolic blood pressure
time frame: 24 weeks
measure: Aortic pulse wave velocity (by cardiac MRI)
time frame: 24 weeks
arm group label: Magnesium
arm group type: Experimental
description: 20 participants will be treated with 400 mg of Magnesium Oxide twice daily
arm group label: Comparator
arm group type: Active Comparator
description: 20 participants will receive no treatment
intervention type: Dietary Supplement
intervention name: 400 mg of Magnesium Oxide twice daily for 24 weeks
arm group label: Magnesium
intervention type: Other
intervention name: Open label (none)
arm group label: Comparator
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Providence VA Medical Center
investigator full name: Wen-Chih Wu
investigator title: Chief of Medicine at the PVAMC and Professor of Medicine at Brown University
mesh term: Heart Failure
mesh term: Obesity
mesh term: Magnesium Oxide