Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis (MagInGlu)

November 29, 2016 updated by: William Weglicki, George Washington University
In most diabetic patients where low blood magnesium levels occur the important depletion of cellular levels is usually not measured. This study will measure both blood and oral mucosal cell magnesium levels before and after 3 months of supplementation with magnesium tablets (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be correlated with blood levels of indicators of inflammation (eg C reactive protein) to see whether the cellular levels are more reliable than blood levels of magnesium for appropriate treatment of magnesium deficiency in diabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The anti-inflammatory effects of oral magnesium (Mg) supplementation of diabetic and metabolic syndrome patients with low serum Mg levels have been studied with increased interest in recent years. However, serum magnesium levels only represent less than one percent of total body magnesium; whereas cellular deficiency of Mg is a more reliable parameter to assess repletion of this essential mineral for correlation with indices of inflammation.

The proposed research will compare the efficacy of a 3 month period of treatment with oral Mg of diabetic patients selected for elevations of CRP, TNFα and other markers of inflammation on cellular and serum levels of Mg.

We anticipate that 50 hypomagnesemic diabetic patients will be selected for 3 months of supplementation with 336 mg of Mg lactate tablets. The repletion of serum and oral epithelial cell Mg levels will be correlated with responses of CRP, TNFα, substance P, HgbAIc and oxidative/nitrosative (ROS/RNS) stress parameters before and after treatment. Individuals will be selected from the Dasman Diabetes Institute in Kuwait. With completion of these analyses, a collaborative manuscript with joint authorship will be prepared and submitted for publication.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

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

  • Kuwait
      • Kuwait City, Kuwait
        • The Dasman Diabetes Institute

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have documented hypomagnesemia (serum levels ≤ 1.8 mg/dL or 0.74mmol/L);
  • Be between 20-70 years of age at the time of randomization
  • Have hyperglycemia due to NIDDM metabolic syndrome or obesity
  • Have at least one abnormal indicator of inflammation (e.g. elevated CRP, TNF-α)
  • Have no active infection

Exclusion Criteria:

  • Currently have significant gastrointestinal disorders (e.g. chronic diarrhea);
  • Have impaired renal function, defined as eGFR < 60 mL/min/1.73m2 or serum creatinine > 1.3 mg/dL;
  • Are current being treated for hypertension (e.g. ACE inhibitors and diuretics), heart block (e.g. EKG evidence of left bundle branch block) or heart failure (e.g. treated with aldosterone antagonists);
  • Are currently pregnant;
  • Have chronic inflammatory disorders (e.g. psoriasis);
  • Have used of Mg supplements and Mg-rich mineral water within 6 months;

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium Lactate
Patients will receive 2 tablets twice a day of Magnesium Lactate for 3 months.
Dietary supplement: magnesium lactate
Patient will be given 4 tablets a day of study supplement (Magnesium Lactate) for 3 months. Magnesium cellular and serum levels will be compared prior and post intervention.
Other Names:
  • MagTabSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The magnesium cellular levels will provide a stronger correlation with antiinflammatory indicators compared to the circulating serum levels of magnesium.
Time Frame: One year
50 hypomagnesemic diabetic patients will receive magnesium tablets (~recommended dietary allowance)for 3 months and circulating inflammatory indicators will be measured. The blood and cellular levels of magnesium will be measured (before and after treatment) to assess which parameter correlates best with efficacy in lowering inflammation indicators.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnesium supplementation will lower parameters of inflammation in hypomagnesemic diabetic patients.
Time Frame: One year
Antiinflammatory indicators (CRP, TNF alpha, isoprostane, Hemoglobin A1c etc) will be measured prior to and after 3 months of magnesium supplementation .
One year

Collaborators and Investigators

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

Sponsor

George Washington University

Collaborators

Dasman Diabetes Institute
Nadia Zghoul, PhD, Dept of Clinical Research

Investigators

  • Principal Investigator: William B Weglicki, MD, George Washington University
  • Principal Investigator: Nadia Zghoul, PhD, Dasmin Diabetes Institute

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

October 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#071317

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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