Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis

NCT ID: NCT01980459

Last Updated: 2016-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-07-31

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.

Conditions

Non-Insulin Dependent Diabetes Mellitus

Keywords

Hypomagnesemia, Cellular Mg, Inflammation, Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Magnesium Lactate

Patients will receive 2 tablets twice a day of Magnesium Lactate for 3 months.

Group Type: EXPERIMENTAL

magnesium lactate

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

MagTabSR

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;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nadia Zghoul, PhD, Dept of Clinical Research

UNKNOWN

Sponsor Role: collaborator

Dasman Diabetes Institute

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

William Weglicki

Professor of Medicine, Biochemistry & Molecular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William B Weglicki, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Nadia Zghoul, PhD

Role: PRINCIPAL_INVESTIGATOR

Dasmin Diabetes Institute

Locations

The Dasman Diabetes Institute

Kuwait City, , Kuwait

Countries

Kuwait

Other Identifiers

IRB#071317

Identifier Type: -

Identifier Source: org_study_id