Non-Insulin Dependent Diabetes Mellitus Clinical Trial
Official title:
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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