Clinical trial NCT01980459: Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis
Official title: Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Insulin Dependent Diabetes Mellitus
Keywords: Hypomagnesemia, Cellular Mg, Inflammation, Diabetes Mellitus
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Nadia Zghoul, PhD, Dept of Clinical Research
name: Dasman Diabetes Institute
First posted: 2013-11-11
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: The magnesium cellular levels will provide a stronger correlation with antiinflammatory indicators compared to the circulating serum levels of magnesium.
timeFrame: One year
Secondary outcomes:
measure: Magnesium supplementation will lower parameters of inflammation in hypomagnesemic diabetic patients.
timeFrame: One year
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: The Dasman Diabetes Institute
Study officials:
affiliation: George Washington University
name: William B Weglicki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dasmin Diabetes Institute
name: Nadia Zghoul, PhD
role: PRINCIPAL_INVESTIGATOR
References: