Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis

Non-Insulin Dependent Diabetes Mellitus Clinical Trial

— MagInGlu  

Official title:

Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980459
• Other study ID #: IRB#071317
• Status: Completed
• Phase: Phase 1
• First received: October 22, 2013
• Last updated: November 29, 2016
• Start date: October 2013
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kuwait: Joint Committee for the Protection of Human Subjects in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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-a)

• 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Non-Insulin Dependent Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Kuwait	The Dasman Diabetes Institute	Kuwait City

Sponsors (3)

Lead Sponsor	Collaborator
George Washington University	Dasman Diabetes Institute, Nadia Zghoul, PhD, Dept of Clinical Research

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The magnesium cellular levels will provide a stronger correlation with antiinflammatory indicators compared to the circulating serum levels of magnesium.	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	No
Secondary	Magnesium supplementation will lower parameters of inflammation in hypomagnesemic diabetic patients.	Antiinflammatory indicators (CRP, TNF alpha, isoprostane, Hemoglobin A1c etc) will be measured prior to and after 3 months of magnesium supplementation .	One year	No