Skip to main content
OpenTrials
Completed

NCT Number: NCT01980459

Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Dasman Diabetes Institute

Kuwait City, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

magnesium lactate

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 .

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

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

Registry information

Acronym: MagInGlu

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2013
Registry last updated
Nov 30, 2016

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.

Published trials that share one or more normalized conditions with this study.