Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis

NCT01980459 | Completed Phase 1

• 1 other identifier: IRB#071317
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Insulin Dependent Diabetes Mellitus

Keywords

Hypomagnesemia, Cellular Mg, Inflammation, Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Magnesium supplementation will lower parameters of inflammation in hypomagnesemic diabetic patients.

  One year

Study Arms (1)

Magnesium Lactate

EXPERIMENTAL

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

Dietary Supplement: magnesium lactate

Interventions

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.

Also known as: MagTabSR

Magnesium Lactate

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• George Washington University: lead
• Nadia Zghoul, PhD, Dept of Clinical Research: collaborator
• Dasman Diabetes Institute: collaborator

Study Sites (1)

The Dasman Diabetes Institute

Kuwait City, Kuwait

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William B Weglicki, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Nadia Zghoul, PhD

  Dasmin Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Biochemistry & Molecular Medicine

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 11, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-11

Locations

KU (1)