The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control

May 17, 2019 updated by: Hartford Hospital

The Use of Magnesium to Improve Hemodynamics, Cholesterol, and Glucose Control: A Substudy of AdMag

The purpose of this study is to determine if magnesium can improve blood pressure, cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators (ICDs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: magnesium L-lactate

Detailed Description

Magnesium is the second most abundant intracellular cation and plays a vital role in many physiologic processes. It has been determined that patients with cardiovascular disease have intracellular magnesium (Mgi) deficiencies. Among the ICD registries in Europe and the United States 64% and 77% of patients also carry the diagnosis of CAD, respectively. Patients with CAD have risk factors that lead to the development and or propagation of atherosclerosis. Paramount among these risk factors are hypertension, dyslipidemia, and diabetes.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the effect they have on cholesterol, blood pressure, and blood glucose.

Study Type

Interventional

Enrollment (Actual)

240

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Connecticut
  - Hartford, Connecticut, United States, 06102-5037
    - Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Newly implanted ICD or recent ICD shock (within 6 months)

Exclusion Criteria:

Inability to swallow
A non-cardiac disease with a survival prognosis of less than 12 months
Hypermagnesemia
Creatinine clearance less than 30mL/min
Lactic acidosis or systemic acidosis syndrome
Previous intolerance to magnesium L-lactate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure, cardiac output, systemic vascular resistance, thoracic fluid content, total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, and blood glucose Time Frame: at baseline, 3, and 6 months of follow-up	at baseline, 3, and 6 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

Principal Investigator: Charles M White, PharmD, University of Connecticut School of Pharmacy, Hartford Hospital Division of Drug Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 25, 2006

First Submitted That Met QC Criteria